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P‑R‑O‑C‑E‑E‑D‑I‑N‑G‑S

(8:05 a.m.)

CALL TO ORDER

EXECUTIVE SECRETARY KRAUSE: Good morning everybody. If we could have everybody find a chair? We're trying to get the speakers. There are still some speakers outside. And it's the staff trying to get them in. So we may have to wait a little bit later, but I think we'll go ahead and get started now. And then if everybody's not quite ready, we'll just hold up a few minutes. But I think we'll get the meeting started so that we can at least try to keep close to schedule.

Good morning, everyone. We're ready to begin the 66th meeting of the General and Plastic Surgery Devices Panel. My name is David Krause. I'm the Executive Secretary of this panel. And I'm also a biologist and a reviewer in the Plastic and Reconstructive Surgery Devices Branch in the Division of General, Restorative, and Neurological Devices.

I'd like to remind everyone that you are requested to sign in on the attendants' sheets, which are available at the tables by the doors just outside. You may also pick up an agenda, a panel member roster, and information about today's meeting out there on the tables.

The information includes how to find out about future meeting dates through the advisory panel phone line and how to obtain meeting minutes or transcripts.

Before I turn the meeting over to Dr. Choti, I'm required to read a statement into the record regarding conflict of interest.

CONFLICT OF INTEREST AND OPENING REMARKS

EXECUTIVE SECRETARY KRAUSE: "The following announcement addresses conflict of interest issues associated with this meeting and is made a part of the record to preclude the appearance of an impropriety.

"To determine if any conflict existed, the agency reviewed the submitted agenda for this meeting and all financial interests reported by the committee participants.

"Conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employers' financial interests. However, the agency has determined that participation of certain members and consultants, the need for whose services outweigh the potential conflict of interest involved, is in the best interest of the government.

"We would like to note for the record that the agency took into consideration certain matters regarding Dr. Miller. Dr. Miller reported his institution's past and current involvement with firms at issue.

"In the absence of personal financial interest, the agency has determined that he may participate fully in the panel's deliberations. In the event that the discussions involve any other products or firms not already on the agenda for which an FDA participant has a financial interest, a participant should excuse him or her self from such involvement. And the exclusion will be noted for the record.

"With respect to all other participants, we ask in the interest of fairness that all persons making statements or presentations disclose any current or previous financial involvement with any firm whose products they may wish to comment upon."

At this point I'd like to turn the meeting over to Dr. Choti, the chairman.

CHAIRMAN CHOTI: Thank you, Dr. Krause, and good morning.

My name is Dr. Michael Choti. I'm in the Division of Surgical Oncology at Johns Hopkins University. And I am the standing chair of this panel.

During this three‑day meeting, we, our panel, would like to make recommendations to the Food and Drug Administration on two pre‑market approval applications.

PANEL INTRODUCTIONS

CHAIRMAN CHOTI: The next item of business is to introduce the panel members, who are giving their time to help the FDA in these matters and the FDA staff here at the table. I'm going to ask each person to introduce him or herself, starting with both the area of expertise, position title, institution, and his or her status on the panel, either voting member or industry. Let me start on the left side of the panel here with Dr. Bartoo.

MEMBER BARTOO: My name is Grace Bartoo. I'm the General Manager of Decus Biomedical. I have experience in biomedical engineering. That's what my training is in. But I also have a lot of experience in clinical trials and medical advice research.

I am the industry representative for the panel.

MEMBER DOYLE: My name is LeeLee Doyle. I have a Ph.D. in reproductive physiology. I am a Professor Emeritus of Obstetrics and Gynecology and currently the Assistant Dean for Faculty Development at the University of Arkansas for Medical Sciences College of Medicine.

I am the consumer representative, a nonvoting member.

MEMBER BLUMENSTEIN: My name is Brent Blumenstein. I am a biostatistician. I work independently from Seattle, Washington.

MEMBER EWING: My name is Cheryl Ewing. I am a faculty member at the University of California at San Francisco in the Department of Surgery in surgical oncology with a specialty in breast oncology.

MEMBER NEWBURGER: I'm Dr. Amy Newburger. I'm a dermatologist in private practice, Director of Dermatology Consultants of Westchester. I teach at St. Luke's‑Roosevelt Hospital Medical Consortium.

MEMBER LoCICERO: I'm Joseph LoCicero. I'm a thoracic surgeon specializing in foregut surgery. I'm Professor and Chair of Surgery at the University of South Alabama.

And I am a voting member.

MEMBER MANNO: I'm Dr. Barbara Manno. I am a toxicologist. I'm a professor with the Department of Psychiatry at the Louisiana State University Health Sciences Center in Shreveport, Louisiana and voting today.

MEMBER LI: My name is Steve Li. I am the President of Medical Device Testing and Innovations in Sarasota, Florida. My areas of expertise are biomechanics and biomaterials.

And I am a voting member today.

EXECUTIVE SECRETARY KRAUSE: My name is David Krause. I am the Executive Secretary.

MEMBER CALLAHAN: I'm Leigh Callahan. I'm a health outcomes researcher, an epidemiologist at the University of North Carolina in Chapel Hill. I'm in the Departments of Medicine and Orthopedics.

And I am a temporary voting member for this panel.

DR. MILLER: I'm Michael Miller. I am Professor and Deputy Chairman of Plastic Surgery at University of Texas, M. D. Anderson Cancer Center.

My clinical work involves cancer‑related reconstructive surgery. I also have appointments in biomedical engineering with the University of Texas Center for Biomedical Engineering and at Rice University.

MEMBER LEITCH: I'm Marilyn Leitch. I'm a surgical oncologist at the University of Texas Southwestern Medical Center in Dallas. I also am involved primarily in the treatment of breast cancer patients but do see patients with benign diseases as well. And I am a professor of surgery.

DR. PROVOST: I'm Miriam Provost. I am Acting Director for the Division of General, Restorative, and Neurological Devices in the Office of Device Evaluation at FDA.

EXECUTIVE SECRETARY KRAUSE: Let me just clarify for the record that Drs. Leitch, Miller, LoCicero, Newburger, Ewing, and Blumenstein are all voting members on this panel. Drs. Manno, Li, and Callahan are deputized voting members. And we will read the deputization memo tomorrow.

CHAIRMAN CHOTI: I would like to note for the record that the voting members present constitute a quorum, as required by 21 CFR Part 14.

Let me read a letter from Dr. Michael Olding, who was to be a member, a nonvoting member, on this panel. He elected not to be present and requested that the following letter be read, "Dear Dr. Choti, I would like to request the following statement to be read into the record at the time of the General and Plastic Surgery Panel meeting.

"On December 2004, I agreed to serve on this panel with great enthusiasm for its mission and with a full understanding of the commitment and the need for impartiality. Accordingly, I completed the required conflict of interest statement in January 2005, indicated that there are no conflicts.

"Subsequently, on March 21st, 2005, Medicus Pharmaceutical Corporation announced plans to merge with Inamed Corporation, a firm at issue. That merger is subject to approval by stockholders, regulatory approvals, and customary closing conditions according to the companies.

"Upon learning of the planned merger, I immediately notified the Executive Secretary of the proposed merger and that I owned a quantity of stock in Medicus.

"Initially, on April 1st, 2005, the Executive Secretary indicated that my service on the panel would not be affected by my stock holdings and the planned merger, but one business day before this meeting, on Friday, April 8th, I received a fax from Integrity Committee and Conference Management Branch informing me that due to the stock‑holding value, between 50,000 and 100,000, in a firm that is slated to merge with a firm at issue, I would be excluded from voting on the panel. It does appear that I would be allowed to 'review and discuss matters before the panel,' even though I am denied the right to vote.

"As the chronology demonstrates, the incipient conflict was created by the decision of the two companies to merge and not by any action on my part. Indeed, I made the FDA aware of the situation.

"I was fully prepared and committed to continuing my service on the panel impartially and a relatively small stock‑holding I have in the company, which until March 2005 had no interest in the outcome of our work, would have no bearing on my decision‑making process.

"I do not feel it is appropriate for me to continue my service on the panel as a partial member; that is, one without voting rights. Since the FDA has concluded that my voting may create an appearance of a conflict due to my stock holdings, I do not want my continued service as a nonvoting panel member to be suspect in any way.

"I regret having to make this decision as I possess important experience as a plastic surgeon for the panel to consider. And my departure will leave only one other professional with similar experience. But the handicap that the FDA has placed upon me because of the incipient conflict, not of my making, that arose since my appointment to the panel makes my decision necessary.

"Thank you for your consideration and understanding. And good luck to you and the panel in your important work. Sincerely, Michael Olding."

Now I would like to introduce Commander Stephen Rhoades, the Acting Deputy Director of the Division of General, Restorative, and Neurological Devices, who will update the panel since the last meeting.

Dr. Rhoades?

CDR RHOADES: Thank you, Dr. Choti.

PANEL UPDATE

CDR RHOADES: I am Stephen Rhoades. I am the Acting Deputy Director in the Division of General, Restorative, and Neurological Devices. Welcome, members of the panel, members of the public, and manufacturers, to this important three‑day meeting of the General and Plastic Surgery Devices Panel on two silicone gel‑filled breast implants.

Tomorrow you will make recommendations and vote on Inamed Corporation's pre‑market approval application. On Wednesday, you will make recommendations and vote on Mentor Corporation's pre‑market approval application.

Because of the high public interest in silicone gel‑filled breast implants, in addition to the regular public comment periods for any PMA discussion, we have scheduled a full day for a public comment on issues related to silicone gel‑filled breast implants.

This panel last met on March 25th of 2004, at which time you recommended approval of Dermik Laboratories pre‑market approval application for their Sculptra dermal filler for lipoatrophy in HIV‑positive patients. This device application was approved on August 3rd with a conditional post‑approval study to evaluate long‑term safety.

On April 22nd of 2004, FDA approved Genzyme Corporation's Hylaform dermal filler for moderate to severe facial wrinkles and folds.

This panel recommended approval of this device at the November 21st, 2003 panel meeting. The approval included a condition for a post‑approval study in patients with Fitzpatrick IV to VI skin types.

On August 9th, 2004, FDA issued a final rule classifying silicone sheeting for the management of closed hyperproliferative scars as Class I devices exempt from pre‑market notification. This panel recommended that these be Class I‑exempt at the July 24th, 2003 panel meeting.

The agency appreciates the commitment of the panel members. And we also appreciate the comments of the representatives of the 30 professional organizations and 145 members of the public who have requested time to address the panel today.

Thank you for your attention. I would now like to introduce Dr. Miriam Provost for a few words.

WELCOMING REMARKS

DR. PROVOST: Good morning. As Commander Rhoades said, I am Miriam Provost. I am the Acting Director for the Division of General, Restorative, and Neurological Devices.

I would like to just take a few minutes and give everyone a brief regulatory background followed by a discussion of why we have convened this meeting and what are we asking you, our distinguished advisory panel, to do.

First, some background on the regulatory status of silicone gel‑filled breast implants. Prior to 1991, silicone gel‑filled breast implants were sold on the market either as pre‑amendments devices, which means they were on the market prior to May 1976, or as a 510(k)‑cleared device.

In April 1991, FDA issued a regulation that required all manufacturers of silicone gel‑filled breast implants to submit safety and effectiveness data in PMAs in order for their products to remain on the market.

Several PMAs were submitted and presented to an advisory panel in November 1991 and then again in February 1992. In April 1992, FDA determined that the PMAs did not include adequate safety data to support approval. However, at the same time, FDA believed there was a public health need to have breast implants available for reconstruction in revision patients.

In 1992, because FDA believed it was important to provide continued availability of silicone gel‑filled breast implants for women seeking breast reconstruction or revision, we developed a new type of study design referred to by industry and the FDA as an adjunct study.

Inamed in 1998 and Mentor in 1992 are the only two companies that have received FDA approval for an adjunct study. Inamed's and Mentor's adjunct studies currently remain active. Both adjunct studies require five‑year follow‑up for each patient enrolled. And there is no limit on the enrollment of reconstruction or revision patients or on the number of investigational sties.

Adjunct studies are focused on the collection of safety data and do not include MRIs screening for silent rupture. The 1992 agreements between FDA and industry also described information to be collected in the study design to evaluate safety and effectiveness to support a PMA, the so‑called "core study."

The investigational device exemption, or IDE, studies are the mechanism by which the core study data, which you will hear referenced during this panel meeting, are collected.

Inamed submitted and received approval for their core study in 1998. Mentor submitted and received approval for their core study in 2000.

At the current time, FDA has not approved any PMAs for silicone gel‑filled breast implants. They remain investigational devices, which means that a patient must be enrolled in an adjunct study or an IDE study in order to receive one of these implants in the U.S.

I'd also like to note that in January 2004, FDA issued a draft update of our guidance document for manufacturers of breast implants. This document is a framework for breast implant manufacturers. And it includes recommendations on the kind of information that FDA recommends be provided in a PMA.

We have received numerous comments on the draft guidance. And at the present time, we are continuing to review the comments that we received. Once we have reviewed the comments and made revisions, as appropriate, the guidance document will be released in final.

It should be emphasized that our review of the information in a PMA is not affected by whether a guidance document for the product in question is in draft or final form. As is the case for all medical device applications, FDA will base our decisions on the scientific and clinical data in the PMAs as well as the panel's deliberations and recommendations regarding those data.

Now for the task at hand. Inamed's PMA, P020056, was presented previously at the October 2003 meeting of the General and Plastic Surgery Devices Advisory Panel. The panel recommended in a nine to six vote that the PMA was approvable with conditions.

In January of 2004, after considering the data in the PMA and the panel's deliberations of the data, we determined that the PMA was not approvable because the data did not provide a reasonable assurance of safety for the device.

Therefore, FDA's presentation at this panel meeting for the Inamed PMA will focus on the additional information submitted by Inamed to address the outstanding safety issues. The Inamed PMA will be the panel's focus on Tuesday.

Mentor's PMA, P030053, is being presented for the first time at a panel meeting. Therefore, FDA's presentation for this PMA will involve a summary of all relevant preclinical and clinical data. The Mentor PMA will be the panel's focus on Wednesday.

It should be noted that, although the core study is the primary source of clinical data for both PMAs, both sponsors use data and information from multiple sources to address the key safety issues.

Based on your own scientific and clinical knowledge, we are asking you, the panel, to discuss the data in each individual PMA and advise us as to whether there is sufficient information to provide a reasonable assurance of safety and effectiveness for each device.

After the panel meeting, FDA will continue to review the information contained in this PMA. We will carefully consider the deliberations and recommendations that you make during this meeting. Ultimately FDA will make a decision on the approvability of these two PMAs.

We will also hear a number of comments from the public today as well as on Tuesday and Wednesday. And I want to thank the members of the public for making the effort to come here today to present their views on these applications.

I want to assure everyone that the FDA will carefully listen to these comments. And, as previously stated, we will make our decision based on the scientific data in the PMAs and the panel's deliberations on the data.

I do want to remind everyone, however, that this meeting is not intended as a general referendum on silicone gel‑filled breast implants. This panel meeting focuses specifically on the safety and effectiveness of two individual breast implant PMAs. And the object of this meeting is to obtain input from you, the panel, on the data in these applications. The FDA is very appreciative of your giving of your time and expertise to accomplish this important task.

Thank you very much. And now I'm going to turn it back over to you, Dr. Choti.

CHAIRMAN CHOTI: Thank you, Dr. Provost.

We will now proceed with the open public hearing session of this meeting. All persons addressing the panel are asked to speak clearly into the microphone as the transcriptionist is depending on this as a means to accurate recording of the meeting.

I would like to have the attention of all of the individuals who are registered to speak to the panel today. You have been given a number of correspondence regarding the order of your appearance.

Please come to the podium area in advance so that we are not spending a great deal of time in transitions from speaker to speaker. And we have two podiums set up in order to alternate and for time sake. The FDA panel will direct you to the appropriate podium.

Please remain within your time constraints as a timer will be present to help you with this. We have many public speakers today. And so it is extremely important that we stay on time.

There is a yellow light that will flash 30 seconds before your time is up. And the red light flashes as soon as your time is up. If you're still speaking at that time, then I will promptly instruct you to summarize and cut off. If after ten seconds that is not done, then I have been told that the microphone will be cut off. So please try to stay to your allotted times.

Also, regarding your written comments, please only bring to the panel your written comments that have been submitted or your presentation slides. No additional material, please.

We would also like to address the issue of financial disclosure. Before the Food and Drug Administration and the public believe in transparent process for the information gathering and decision‑making, to ensure such transparency at the open public hearing session of the Advisory Committee meeting, the FDA believes it is important to understand the context of an individual's presentation.

For this reason, the FDA encourages you, the open public hearing speaker, at the beginning of your written or oral statement to advise the Committee of any financial relationship you may have with the sponsor; its product; and, if known, its direct competitors. For example, this financial information may include the sponsor's payment for your travel, lodging, or other expenses in connection with your attendance at the meeting. Likewise, the FDA encourages that you at the beginning of your statement advise the Committee if you do not have such financial relationships.

If you do not choose to address this issue of financial relationships at the beginning of your presentation, it will not preclude you from speaking.

Let's begin with the first speaker. These individuals are the ones who have notified the FDA of their intent to testify during the open public session.

The first speaker, please? Thank you. Good morning.

MS. JOHNSTON: Thank you.

OPEN PUBLIC COMMENT

MS. JOHNSTON: Good morning. My name is Kathy Keithley Johnston. I'm the Executive Director and founder of Toxic Discovery, a national not‑for‑profit consumer advocacy organization. I am also a registered nurse. And I myself used to have silicone gel breast implants. I have no conflicts of interest.

I am here today carrying the voices of thousands who have been directly affected by the failure of the FDA to require long‑term safety studies concerning breast implants.

We believe the FDA made the right decision in 2004 when they decided not to approve Inamed's silicone breast implants. The new guidance that the FDA issued at the same time was an important step forward, demonstrating the FDA's commitment to assure that breast implants are safe for long‑term health studies before they allow them to be widely sold.

I am here today counting on you to help the FDA to adhere to the guidance document. Silicone breast implants should not be approved until a company can prove the safety of devices for long‑term use. Since safety cannot be proven, we ask you to deny the manufacturer's application.

Implant lobbyists claim that there are over 100 studies of women with implants that show no evidence of harm. That is clearly and absolutely false. These groups conveniently ignore the following studies: a study by the FDA of women with silicone breast implants that at least found for six years that women had at least one failed breast implant, even though they did not know it. This is referred to as a "silent rupture."

That same study found that 21 percent had silicone leakage outside the scar capsule surrounding their implant. From there, silicone could harm breast tissue, could migrate into lymph nodes and, thereby, travel to lungs, liver, or other vital organs.

The FDA also found that women with leaking silicone breast implants were more likely to report fibromyalgia and other connective tissue diseases. Scientists at the National Cancer Institute found that women having breast implants for at least seven years were twice as likely to die of brain cancer, three times as likely to die of lung cancer, and four times as likely to commit suicide compared to other plastic surgery patients.

A Canadian study found that women with breast implants for augmentation were more likely to be hospitalized and had more physician visits than women of the same age living in the same communities.

These are just a few of the studies that were a serious concern about risk of silicone leakage. Research has not yet been done to determine exactly what chemicals leak into a woman's body and what long‑term health consequences then results from that leakage and migration of silicone. How can informed consent be obtained when information is not even known by the very physician implanting these risky devices?

Neither Inamed nor Mentor has conducted studies of the health impact of leaking silicone in a woman's body. Dow‑Corning has funded one such study. In a Danish study, Holmich claimed that leakage was not significantly related to connective tissue disease. However, there were only 23 women in this study with extracapsular leakage, a sample that is much too small to provide meaningful safety data. In fact, the study showed that women were four times as likely in that study to report a connective tissue disease compared to women whose implants were not ruptured. But these impressive differences were not statistically significant because the sample was too small.

You would certainly think after 40 years that implant manufacturers should find more than 23 women with extracapsular rupture. Without a doubt, there are more than 40 in this very room today. There are hundreds of thousands of women in this nation whose body would show you that leakage is present if testing was provided.

Our organization has serious concerns about the integrity of the studies conducted by Inamed and Mentor. Patients in these studies have informed us of their fears that they believed that their problems with implants were never reported by their physician or the manufacturer.

In closing, let me remind you of the duties of the FDA. First and foremost, the FDA is a public health agency charged with protecting American consumers. The FDA should be the consumer watchdog and not the advocate of the breast implant manufacturer.

It is your job to make sure that the FDA protects patient safety concerning breast implants. This can only be done by requiring long‑term health studies before approval and not after approval.

It is certainly not your job to protect the livelihood of plastic surgeons or implant makers. Both have failed in their promises to protect women, which will not make the situation better. It will only allow it to continue. And we ask you, please protect the women of this nation.

CHAIRMAN CHOTI: Thank you.

Next speaker?

MS. GROSS: Good morning, panel. I am Marcy Gross. I am a consultant who specializes in women's health issues. I am a member of the State of Maryland Women's Health Promotion Council and serve on the boards of various private health organizations.

Prior to becoming a consultant, I worked for the Department of Health, U.S. Department of Health and Human Services, where I was a Senior Policy Analyst for a number of years in the Office of the Assistant Secretary for Health. And in my last position, I was the Senior Adviser for Women's Health at the Agency for Healthcare Research and Quality, where I served while there on the secretarial ad hoc task force on silicone breast implants.

I give you this resume to establish my familiarity with the issues at hand. However, I am speaking as a private citizen. I have no financial links to any of the applicants.

A legacy from my six‑year tenure at AHRQ is an appreciation of the need for a strong evidence base to support medical decisions. One of my concerns today is that an adequate evidence base for the approval of silicone gel breast prosthesis still does not exist. Worse, a truly long‑term gold standard study that will produce independent, objective research findings seems not to be on the horizon.

We do have 40 years of experience with breast implants, including 25 years when the silicone implants were available to women, all women. They were pulled from the market for good reason. They were associated with major medical problems.

The basic facts on this issue have not changed in the 14 years subsequent. First, available studies on the health aspects of silicone gel implants are still short‑term and are often produced by companies that manufacture the devices or materials.

Second, the work that is available, some from FDA itself, indicates that the rate of complications of implantation, reinfections, reoperations, and other adverse events are sufficiently high to remain a major concern, despite advances in materials.

Third ‑‑ and this is a change from the past ‑‑ the Mentor applicant agrees that the devices will not last indefinitely and warned women that they should expect to have them replaced. So the issue becomes one of sequencing in looking at the data. Do we get the data first and approval after or the reverse?

Letting women be living testers I find highly objectionable since these are elective procedures and there are alternatives, especially since the data on improvements in the quality of life for patients undergoing implantation are weak by accepted research standards and most especially since it is expected the devices will fail and will have to be removed.

On this last point, the overall failure rate, it should be noted that Mentor acknowledges that their devices will have a finite in vivo life, which means, really, that all will fail and need to be surgically removed. We just don't know when.

I would assert that if this were an NIH‑funded research study, it's unlikely it would go forward.

CHAIRMAN CHOTI: Please sum up for us.

MS. GROSS: Yes, please. I just ask that you have the data in hand before you reintroduce the silicone breast implants. Thank you for your time.

CHAIRMAN CHOTI: Thank you.

Let me remind the audience that speakers have three minutes unless it's a national organization. And then it's five minutes.

Yes, next speaker?

MR. SCHULTZ: Good morning. My name is William Schultz. I am representing a group of women's organizations led by Command Trust. I appreciate being given five minutes. Thank you.

Thank you for the opportunity to address this Committee on the very important question of whether FDA should approve the applications for silicone gel breast implants. For the record, I have no financial ties to either of the applicants.

Congress enacted the medical device amendments in 1976 in the wake of several tragedies, including the Dalkon shield IUD, which killed 16 women and injured countless others. Congress sought to remedy the defect by a new law, the defect being that medical devices were being marketed without any demonstration of their safety or any adequate testing.

Congress was particularly concerned about the safety of implantable devices. The basic showing that it required manufacturers of these devices to make was that there was a reasonable assurance that the device was safe and effective. In the case of breast implants, efficacy is obviously not the issue. Instead, the issue is safety.

If you think about it, for a therapeutic product, such as a heart valve, the safety standard entails a weighing of risk versus benefits to health. And so FDA may approve a product with substantial risks if it finds the benefits are even greater.

But for a cosmetic product, which is what we have before us today, there are no therapeutic benefits. For these products, the law does not allow approval if the product is associated with significant risk or even if there is significant uncertainty about safety. And I think that is a very important principle to keep in mind as we go through the next three days.

It is also relevant that the manufacturer has the burden of proof. Where there are doubts or uncertainties, then the product may not be approved because the manufacturer has not carried its burden. The law does not contemplate that the patients or consumers should bear the risk of unanswered questions.

At the October 2003 Advisory Committee meeting, there was discussion of various approval conditions and post‑market studies. First, the Committee should understand that any approval conditions are not enforceable by FDA. Once the agency approves a product, then physicians are allowed to deviate from restrictions on the use of the product. And FDA has no authority to enforce those restrictions.

Second, while post‑market studies may be useful, they cannot substitute for the basic safety standard in the statute. The statute does not provide that the agency may approve a product now and allow the demonstration of safety at a later date.

At the last Advisor Committee meeting, there was also discussion about whether women should have the option or the choice of using breast implants as long as they were fully informed.

Although Congress has adopted the buyer beware approach for dietary supplements and in other areas, this was not the approach that it adopted for medical devices. Instead, for these products, it has declared in law that medical devices are not to be available until the manufacturer has demonstrated safety. It is this Committee's charge to do its best to apply that law.

Congress' approach has two important benefits. First, it means that patients and consumers can be confident of the safety of device products that they use. It also creates an important incentive to the manufacturers to design their products to meet the high standard that Congress established.

Significant questions have been raised about the safety of breast implants. I'm not going to address those. But it's important, of course. These products are going to be in the body for many years. Even though the manufacturers have known about the standards of the statute for more than 25 years, we don't really have long‑term data. And given the extremely high breakage rate of these products, lack of long‑term data raises serious problems.

In January 2004, FDA determined that the evidence was not adequate. And the question that this Committee must look at is whether the companies have produced additional data that is sufficient to justify approval.

In conclusion, approval of silicone gel breast implants without an adequate demonstration of safety would have two very unfortunate consequences. First, we would have lost the opportunity to require that these products be adequately tested.

And, perhaps even more important, such a decision would send a message to other product manufacturers that the door has been open for approval of medical devices that do not meet the safety requirements established by law and that patients will suffer.

Thank you very much. And good luck.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. HELMAN: Hi. Good morning. I'm Susan Helman from Florida. I have paid my own way here because I feel that this panel needs to hear from women like me.

I had breast implants for 15 years and suffered greatly. My implants ruptured. And after numerous surgeries to remove silicone from my body, the last surgeon stated, "There is no way to remove it all, Susan. It's migrated to all your tissues, your organs. It's everywhere." Silicone as well as platinum was found in my cheek cells, bone marrow, and lymph nodes, also in my urine and in my blood.

My urine platinum levels when measured eight years after explantation were 25 parts per billion, which is within the range of patients receiving chemotherapy agent cisplatin. The urine platinum level in the general population is .04 parts per billion. So mine was more than 500 times greater.

The platinum ion in my urine and in my tissues I found was the exact match to my implants that they studied as well. My body is full of ionized platinum with no known way to remove it.

As you know, the CDC has identified platinum as a suspected toxin. Because of my ruptured implants and the resulting exposure to silicone and platinum, I have been diagnosed with MS and lupus and fibromyalgia and scleroderma among many other things.

And I'm sick. And I can't get health insurance. When I need it the most, I can't get it. I don't want anybody else to suffer this way. I get severe disabling headaches and nausea when I am exposed to exhaust fumes or unusual odors of any kind, and I never had this problem before ever.

I'm also concerned about young women of childbearing age and their children. I've heard that platinum can be transmitted in milk. And I have platinum in my urine. So, you know, I see no reason why it couldn't be in breast milk.

Any mother would be heartbroken to find out that during a cosmetic surgery, unbeknownst to her, it caused her breast milk to be adulterated and cause injury to her newborn child.

I just ask that before implants are considered safe, platinum testing be done on a random sample of women with silicone gel breast implants and on women with implants, the breast milk of women with implants.

And, in closing, please, please, please vote against the gel‑filled breast implants until you're sure that the benefits far outweigh the risks. The first oath a doctor learns is do no harm.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. GLICKSMAN: Mr. Chairman and members of the panel, my name is Dr. Caroline Glicksman. And I am reading the testimony from my patient Valerie Hartwell, a 45‑year‑old mother of 3 who is unable to attend today because of work requirements.

"I would like to advise the Committee that I have no financial relationships with anyone connected at this meeting. I had silicone breast implants for two years. I had them put in because of a chest wall deformity I was born with that caused a considerable and noticeable depression along the sternum on my right side.

"The size of one of my breasts was considerably smaller than the other, causing me to be extremely self‑conscious my whole life. I would not wear bathing suits or shirts with a neckline lower than my collarbone because my deformity was so obvious.

"I am so thrilled that I had the silicone implant option available to me. It has made a dramatic difference in my self‑esteem. My self‑confidence has improved drastically.

"I have one anatomical implant on the defective side, which has helped with the depression along my sternum. The other implant is round, to create uniformity. I have had absolutely no side effects.

"My breasts remain soft and natural‑looking, which is very important to me. They feel natural as well. I am able to sleep comfortably in any position. I have had no problem with hardness and no dimpling.

"My husband and I were concerned that I would lose nipple sensitivity. That has not been the case at all. I am so pleased with the results. I am a grateful recipient of a wonderful product that has made a huge difference in my life.

"Thank you, Valerie Hartwell."

CHAIRMAN CHOTI: Thank you.

Next speaker, please? Good morning.

MR. BRENT: Good morning. My name is Ed Brent. And I am representing my wife, P. J. Brent, and our children.

My wife had silicone breast implants for ten years. She had no problems at first but became increasingly ill. On May 29th, 2000, my wife committed suicide. She left behind seven children. On behalf of my wife and my seven children, I urge this panel and the FDA not to approve silicone breast implants unless there is clear evidence that the implants being sold now are safe for long‑term use, meaning ten years or more.

Several studies have shown higher rates of suicide among breast implant patients. And a National Cancer Institute study found that women with implants were four times as likely to kill themselves as other plastic surgery patients.

The implant makers think the explanation is that women with breast implants had lower self‑esteem before they got their implants, but there is no reason to think that women who decide to get implants have lower self‑esteem than women who decide to get liposuction, nose jobs, or any other plastic surgery.

My wife was not a woman with low self‑esteem. She was a vibrant, loving wife and mother. P. J. loved the way she looked the first few years after her implants. Then she began to get sick, and her joints hurt, her fingers would swell. She had lupus‑like symptoms and was diagnosed with fibromyalgia.

P. J. breast‑fed two of our daughters after getting implants. Both are seriously ill. My daughter Catherine, who is with me now, was diagnosed with chronic inflammatory demyelinating polyneuropathy as well as esophageal motility disorder. She spent years in leg braces, and now the leg braces have been replaced with a wheelchair.

Our daughter Christine also has esophageal motility disorder and leg weakness as well. In contrast, our five children born before my wife got breast implants are perfectly healthy.

After P. J. committed suicide, an autopsy was performed. Large amounts of platinum were found in her body. And a doctor at the CDC after seeing the amount of platinum in P. J.'s body said she could not have been in her right mind.

Tissue samples from our daughters who had breast‑fed found that they, too, had elevated platinum levels. These findings were presented at a meeting of the American Chemical Society last year.

P. J. felt terrible guilt that her two daughters had been so seriously harmed by her decision to get breast implants. It was not her fault. She had no way of knowing what would happen. Most doctors did not know that there had not been any long‑term studies on the breast implants.

Just two months before my wife's death, she testified at a previously FDA meeting on breast implants. She felt the panel ignored testimony given by women with implants.

And I am here today to ask you to listen to these patients and their loved ones and do not endorse a product not proven safe for long‑term use. Women and their yet unborn children may be forever affected. This is a scientific issue and a moral issue.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next? Good morning.

MS. HICKEY: Good morning. I am Lisa Hickey, and I am from Phoenix. I have no conflicts of interest.

I am here to tell you I experienced four surgeries in four years due to complications with implants. My experience involved three manufacturers and new and improved products. Two of the surgeries were back to back after a rupture occurred.

Concurrent with the implant exposures, I experienced serious systemic illness and visual and motor impairment, which improved considerably after the implants and capsules were removed.

After the rupture diagnosis, I was required to sign a Mentor informed consent document in order to receive replacements. That occurred after a moratorium had been placed on the implants that I knew nothing about.

During prep for the rupture removal, I was sedated and negotiated with for my rupture evidence. My baseline mammogram and evidence were taken away from me around the same time as that surgery.

If implants are so safe, why are there gag orders and sealed documents regarding silicone implants from an historical perspective? Now I understand that the Justice Department has entered a settlement agreement with manufacturers for recovery of enormous expenses paid out to Health and Human Services claims for breast implant complications.

Aren't Social Security and Medicare in enough trouble already? How is it that the Justice Department can recover its losses with the Daubert rule in place, not allowing important evidence from expensive medical testing, while at the same time there is a law in place requiring insurance to cover breast cancer reconstruction with implants?

And I have been told the Navy Department is conducting a large breast cancer study. I am a furloughed flight attendant for a struggling airline that is required to pay for products with high complication rates for reconstructions when the Justice Department is trying to recover U.S. losses incurred by enormous claims from complication.

Now, I do not have a fancy degree or knowledge about rocket science, but my grandparents were educators. And they taught me to read the road signs on the highway of life. I can read that things just don't add up to safety when it comes to silicone gel.

Many of my fellow flight attendant friends and acquaintances with implant exposures have been ill. And some have passed on in the prime of their lives.

Is silicone research taking place in the morgue? In your approval process, please consider what this research does not tell you. Breast implant exposures altered my health forever. Believe me, experiencing illness serious enough to have my implants cut out in hopes of feeling better did not improve my self‑esteem.

I implore you to help ensure that what happened to me and my friends with silicone exposures never happens to anyone else, especially young women in childbearing years, single mothers with limited financial resources, and vulnerable cancer patients.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next? Good morning.

MS. P. DOWD: Good morning. Mr. Chairman, ladies and gentlemen of the panel, I thank you for this opportunity to come before my government and speak on the dangers of silicone gel breast implants. I come as a little David to approach the giants of the silicone industry.

My name is Pam Dowd of Boise, Idaho. I represent Implant Veterans of Toxic Exposure. I have driven almost 2,500 miles in a 1984 Southwind motor home at my own expense to be here. I felt it was that critical.

On May 21st, I will reach my 30th year of being free of breast cancer. In 2003, I told the panel about my experience as a breast cancer survivor and about the failed reconstruction that included three ruptured silicone breast implants. I told the panel about the excruciating pain of a spontaneous rupture that literally had me pulling at my hair, about the experience of having my chest scraped and cauterized following the explant, and that the Mentor implants of 1988 that caused me to cough constantly and choke on my own saliva for seven years, and about the pain in the long bones that at times has me screaming in pain.

Today I come to address the issue of the denial of health care insurance for women who have had breast implants. On page 5 of the Mentor Corporation 48‑page informed consent is this warning. Inamed does not provide this information online. "For patients who have undergone breast implantation, either as a cosmetic or a reconstructive procedure, health insurance premiums may increase, coverage may be dropped, and/or future coverage may be denied. Treatment of complications may not be covered as well. You should check with your insurance company regarding these coverage issues."

Ladies and gentlemen, there is no "may" about this critical health crisis with implanted women. The denial of health insurance to women who have had implants is increasing across the land. Until last year, I had no personal knowledge of being denied health insurance.

Last October, my late husband went on Medicare. And we lost his COBRA insurance. For 30 years, I had been covered under group policies. Blue Cross had paid for this devastation that's called breast reconstruction. Yet, in the end, I am denied health insurance based on the diagnosis of Sjogren's, Raynaud's, peripheral neuropathy, fibromyalgia, and a long list of other diagnoses I have received since getting breast implants.

Insurance companies such as Blue Cross/Blue Shield, Equitable Life Insurance, Aetna, AARP supplemental insurance, Prudential, Republic Bankers Life Insurance, Times Insurance Company are denying health care coverage to women who have had breast implants.

I found evidence on the evidentiary CDs from the MDL that this concern was first reported by doctors in 1989. Insurance application forms are now asking for implant history.

If, as the manufacturers and members of the ASPRS repeatedly claim, there is no connection between implants and health problems, then why the insurance denials? If there are no health risks, then why does Blue Cross/Blue Shield of Texas have declined if implants are explanted as their underwriting guidelines as far back as 1996? What is the toxic secret the insurance companies know but aren't sharing?

In 1998, I presented the results of a survey of implanted women to the Institute of Medicine. Of the respondents, 30 percent of the women were on disability and are drawing assistance for living needs from government and charity offices. Many of those who were disabled were disabled before the age of 50 and within 15 years of getting breast implants.

With Inamed's latest figures of 325,000 newly augmented women per year, this has the probability of creating another 100,000 women on disability a year within the next 15 years. This has the potential of being in excess of $100 million burden on the American taxpayer.

On pages 40 and 41 of Mentor's 48‑page informed consent are Mentor's support of the diabolical and barbaric flat surgeries that are disabling, creating permanent and sometimes total disability for the recipients.

The insurance companies are already saying they are not going to pay for the health care needs of even the reconstruction patients they have already covered.

Ladies and gentlemen, it will be seven and a half years ‑‑

CHAIRMAN CHOTI: Would you please sum up?

MS. P. DOWD: ‑‑ before I am eligible for Medicare. I am 57, uninsured, and uninsurable.

CHAIRMAN CHOTI: If you could please sum up for us?

MS. P. DOWD: Yes.

CHAIRMAN CHOTI: Your time is up.

MS. P. DOWD: Putting the burden of health care of thousands of women on my child's shoulder is a task I could not in good conscience do. Can you?

Again, thank you for this opportunity.

CHAIRMAN CHOTI: Thank you.

Next? Good morning.

MS. B. DOWD: Good morning. Mr. Chairman and members of the panel, I appreciate the opportunity to speak to you about the dangers of silicone breast implants.

My name is Brenna Dowd. I am from Boise, Idaho. I came with my mother in our old motor home. We used my father's life insurance money to get here.

Ever since I have been old enough to pay attention to my mother's health, she has been sick. My dad died in December. And now we are alone, and I have to take care of her.

I have never known a healthy mother. Mom will never tell people about all the times she has been unable to walk right, sometimes crawling, many times falling. She would never tell you about the times when she gets confused or when her legs hurt her so much she has to sit in a hot bath maybe three times a day or more just to ease the pain because of the silicone breast implants.

Mom will never tell you how she fell out of the motor home on the way here and I was afraid she wouldn't be able to finish the trip or when we got to Hagerstown Saturday night, she was too exhausted to even eat.

My mother liked to go camping in the mountains in Idaho with my father. She hasn't been able to do that for a long time. She gets too tired to do anything physical.

Mom has never been able to do many things other moms should be able to do with their children, such as shop all day in the mall or play real hard with me. Even simple walks exhaust her. She tries, but she is too sick.

In closing, I leave a message from my father. One of his greatest regrets in life was that he had not protected my mom from the implants and that she could not get health insurance. He blamed himself, but Dad was not to blame. These companies that sell implants to innocent women and make them sick are the ones who should be held accountable. They poisoned my mother and robbed me of a healthy mom and my father of a healthy wife.

I beg you to please ban silicone breast implants. Thank you.

CHAIRMAN CHOTI: Thank you.

Next?

DR. BERMAN: Good morning. I'm Dr. Alan Berman, Executive Director of the American Association of Suicidology located here in Washington, D.C. For 37 years, the AAS has had as its primary mission that of understanding suicide as a means of promoting human welfare.

I come here today at my own expense with no financial ties to either sponsor or any of their competitors. The majority of Americans report having thought about suicide at some time in their lives. Most everyone decides to live because they come to realize that their pain is temporary but death is not.

On the other hand, some people in the midst of a crisis perceive their problems as inescapable and feel utterly hopeless. Tragically, some 31,000 Americans take their lives annually.

The AAS believes it is essential to have sound empirical study of suicide. I am here to briefly discuss five studies that have shown an increased risk of suicide among women who have undergone breast augmentation.

Scientists from the NCI reported that breast augmentation patients were four times as likely to kill themselves as were other female plastic surgery patients matched for age, socioeconomic status, health status, and habits. It is important to note that all the women in this study had implants for at least seven years, much longer than in other implant studies. A weakness of the study was the confounding variables, such as depression or marital discord, were not controlled.

Three European studies, one each from Sweden, Finland, and Denmark, consistently found that women who had had breast implants for augmentation were three times more likely to complete suicide than women in the general population of those countries.

In the U.S., a recent study of mastectomy reconstruction patients also found a higher rate of suicide among implant patients compared with women who underwent mastectomies without reconstruction.

The American Society of Aesthetic Plastic Surgeons and Dow‑Corning funded articles concluding that the increased risk of suicide likely existed before surgery. They argue that women who get breast implants may be more likely to suffer from low self‑esteem and/or depression. In addition, based on their demographics, they may be at higher risk for suicide.

But the research data does not back this up. One study noted that eight percent of Danish augmentation patients had a psychiatric admission before surgery compared to six percent of women who had other cosmetic procedures. Danish women, however, had to get psychiatric referrals before they could get free augmentation from the public health system. Clearly, this could be the reason behind this insignificant difference.

Implant patients, like most plastic surgery patients, tend to be unhappy with the specific body part they want changed. But they are not less satisfied with the overall appearance or with themselves.

A Danish study found that women who had breast implants for augmentation were five to seven times more likely to be taking antidepressants than women who had breast reduction surgery or women in the general population. Women who had their implants removed and replaced at least one time were also more likely to be taking antidepressants than women who still had their original implants.

The relationship between multiple implant surgeries and the use of antidepressants may be, in part, because complications from implants contribute to depression, but it is not possible to know if these women had a prior history of depression.

Women with breast implants who testified before the FDA in October 2003 provide anecdotal evidence for the connection between pain following augmentation surgery and suicidal thoughts. Several women described feeling depressed and suicidal as a result of debilitating pain, fatigue, and mental confusion, years after getting silicone breast implants. They said when the implants were removed, their health improved. And they experienced less depression and less suicidal thinking.

Anecdotal case reports such as these are for qualitative data that informs hypothesis testing that simply has not occurred to date. We have here an ad hoc challenge/dechallenge test that has never been studied or rechallenged empirically.

It is possible that women who undergo augmentation have lower self‑esteem than other women, but studies have not supported this. Again, studies show that women who plan to undergo augmentation tend to feel less attractive regarding their breasts but do not have overall lower self‑esteem or self‑confidence.

There is no a priori reason to believe that women who decide to undergo breast augmentation have lower self‑esteem or are more depressed than women who undergo liposuction or other plastic surgery procedures.

Interestingly, while breast implant manufacturers attribute suicide excess to pre‑implant psychiatric disorders, they also maintain that implants improve a woman's self‑worth. There are no studies to support this assertion either.

The bottom line is that every published study on suicide and breast implants shows that there is an increased risk of suicide. The question is why.

No prospective study of depression before versus after augmentation has yet been reported. No study has yet examined post‑surgical outcomes among patients who later completed suicide. Well‑designed, case‑controlled psychological autopsy studies are needed to make differentiations and/or links between preoperative and postoperative risk variables.

Thank you.

CHAIRMAN CHOTI: Thank you.

Good morning. Next?

MS. HOUSER: Good morning. My name is Christie Houser. I have no conflicts of interest. I'm a 47‑year‑old mother of 2 boys and a full‑time first grade teacher's assistant. I got silicone implants for augmentation at age 25. I researched my particular implants and was told by every doctor that everything would be fine and that the implants would outlive me.

Everything was great for a while, but after five years, I started experiencing joint problems, flu‑like symptoms, rashes, and a cough that wouldn't go away. The doctors told me that the symptoms could not be related to the implants. And I believed them and trusted them.

The implant makers will present four years of studies tomorrow. If I had been included in these studies, most of my problems would not have been seen. We must have real long‑term studies to truly evaluate the safety of the product.

Silicone implants have been on the market for 40 years. Yet, the industry has never presented more than four years' worth of data. Why is that? What are they afraid of? I believe we need to ask the long, hard‑term questions.

Eventually my health got so bad that I had an MRI and an ultrasound. They found that there was something behind my left breast, but they couldn't really see exactly what it was. The implant was covering it. So they couldn't really tell.

When they removed my implants ten years after augmentation, the outer coverings of both of my implants were gone. There was a golf ball‑sized cyst behind my left breast, which they could not see with an MRI or ultrasound. And both implants were ruptured.

They removed the implants and as much silicone as they possibly could and sewed me up. After two months of the surgery, I noticed that my scars were not healing and they were tender. I went to the doctor, and he told me that it would take time to heal.

I went to another doctor. And he saw something that was trying to come out of the scar. In fact, it was silicone that was leaking out of my scars in places that were not healing.

I have two sons. They both have diseases that are unusual. My 16‑year‑old son has Hashimoto's thyroid disease, which is typically found in adult women over 30. My eight‑year‑old has something called urticaria pigmentosa, which is a cafe au lait spot that can blister and previously has put him in anaphylactic shock.

There is no evidence showing that my son's illnesses are through breast‑feeding, but it does beg the question. How did they end up with these strange diagnoses?

There are too many unanswered questions to approve this product. The American people look to you to guide their health and their children's health. I am not against implants, but if we do not demand the research to determine that silicone implants are safe for long‑term use, we have to answer a new generation of women and their children with serious, serious health problem.

Thank you so much for listening.

CHAIRMAN CHOTI: Thank you.

MS. VAN FOSSEN‑NYE: Good morning. My name is Kathleen Van Fossen‑Nye. I drove here from Sinking Spring, Pennsylvania to speak before the panel. And I have no conflict of interest. I spoke before the panel in October of 2003.

My history with silicone breast implants is almost as long as the products have been on the market. In 1968, when I was 22 years old, I was implanted with the original Cronin implant following a bilateral mastectomy for a precancerous condition.

A military doctor performed my first breast implant surgery because my husband was in the U.S. Navy. In the government lawsuit, manufacturers agreed to pay five government agencies, including the Department of Defense, the Department of Veterans Affairs, Medicaid, and Medicare, millions of dollars to reimburse them for the costs they incurred treating women made ill by silicone breast implants. This settlement demonstrates that the federal government is aware and has acknowledged that silicone breast implants cause health problems and disabilities.

However, how can the FDA even consider approving these PMAs when the Department of Health and Human Services has already made it clear that silicone breast implants pose a serious health risk to women, costing millions of dollars?

In the past, I have heard the panel members ask why so many women get breast implants and why they keep getting them, even after they fail? I have heard plastic surgeons on the panel say that the women don't mind the complications because they really like their implants. This was not true for me.

I started to suffer from fatigue and joint pain, and the implants were hard and painful. I went to a number of plastic surgeons, asking to have my implants removed. I found a plastic surgeon who was willing to remove the implants. He removed and replaced my implants with a new and improved implant. This started my journey through a silicone nightmare.

I have experienced the gamut of problems, including outright rejection. Eventually necrosis developed, and the implant actually came out through my skin and popped out on its own. Here is the photo of what happened.

Despite my mastectomy, I developed breast cancer in '86. I have had a total of 15 implants and expanders over the years. Why did I have 15 implants? I had so many because I believed my doctors when they told me they were new and improved. I wanted to believe my doctors when they told me they were new and improved.

For over 35 years, I have experienced new and improved implants. I have come to the conclusion there is no such thing as a new and improved silicone breast implant.

CHAIRMAN CHOTI: Thank you. Good morning.

DR. GLICKSMAN: Mr. Chairman and members of the panel, I am a plastic surgeon practicing in New Jersey for 15 years. I have not received any financial support from any implant manufacturer. And I traveled here at my own expense.

Before I get to my statement, I have a quick comment regarding Dr. Olding's letter to the panel. This development clearly demonstrates that the FDA's review process is flawed. They have no backup plan and no provisions for an alternate panelist. I now have serious questions about the FDA's ability to conduct fair hearing.

I am testifying again, as I did in 2003. And the question today should be what has changed since 1992. Now, clearly we have the evidence‑based science to demonstrate the safety and efficacy of these implants. Over 15 years of study show no link exists between silicone and systemic illness.

What has changed in the last 20 years are the devices, the surgical techniques, and the role of plastic surgeon as both physician and educator. And, most importantly, we now encourage the shared responsibility of the patient to maintain good breast health by follow‑up exams and replacement of their implants as necessary.

The devices used today have evolved dramatically from those of the '70s and '80s. I can tell you that the devices, surgical techniques, and our preoperative patient evaluation have changed so dramatically that my reoperation rate at five years is less than three percent.

But what about the patients? How do you get American women between 18 and 80 to choose a board‑certified plastic surgeon to understand the concept that a breast augmentation is not just a boob job and every pretty blonde does not have to be a D‑cup? Here's where a new generation of plastic surgeons under a new generation of leadership has made their greatest strides.

Manufacturers in the plastic surgery societies have in place courses that teach the techniques that reduce the reoperation rates. We have published algorithms that can help reduce the cycle of reoperations for implant complications. And we have created Web sites where American women can research their choices and become fully informed of their potential risks and benefits of implants, even before they step into a doctor's office.

Women demand and deserve a better level of health care. No medical device lasts a lifetime. And technology now exists, such as MRIs, that can evaluate the integrity of silicone implants as they age.

Even with these changes, we cannot force American women to choose a board‑certified plastic surgeon or return for follow‑up care, just as we can't force adults to quit smoking, lose weight, or wear their safety belts. But we should not limit the use of an implant that has been shown to be safe and effective in study after study because it is used for aesthetic reasons, purely for the enhancement of a woman's self‑esteem.

No different is it from drugs for erectile dysfunction. Their sole purpose is to improve a man's self‑esteem and quality of life and were approved by the FDA without controversy.

As a plastic surgeon, I have performed thousands of implant surgeries using both silicone and saline. I have found silicone to be safe and effective and far superior.

In 1876, William Welch, the founder of Johns Hopkins Medical School said, "In the end, our preconceived beliefs must change and adapt themselves." The facts of science will never change. I base my medical decisions on fact, and the FDA should do the same.

I urge the panel to make a determination on evidence‑based science, not politics and emotions, and leave the choices up to individual women and their physicians.

CHAIRMAN CHOTI: Thank you.

Next speaker?

BETH: My name is Beth, and I have no conflict of interest. To protect my family's privacy, I thought long and hard about whether I should come and testify today. I decided that because of my concern for children born to implanted mothers, I would come at my own expense to tell you how I became convinced that the platinum and other toxic chemicals found in breast implants have harmed my health and that of my two young daughters.

For privacy, I will refer to them as "Muffin." She's seven. "Stinkerbelle" is nine. Both of my girls have tested for lupus due to their extremely high platinum levels, especially Muffin. We have been told that her bones are deteriorating. Here is my story.

After ten years of implantation, a chronic cough caused my right implant to herniate outside the scar tissue. Due to numerous symptoms, including hair loss and swollen lymph nodes. My implants were removed in '92 without replacement.

Two years later I became pregnant with my third child, then my fourth. I was plagued with autoimmune symptoms during these pregnancies, swollen lymph nodes throughout my body, and weight loss. I was so ill in this last pregnancy with Muffin that my doctor informed me that she was living off my body fat.

Published research shows that platinum is stored in the fat of breast‑implanted women. I am convinced this is why Muffin has an even higher lupus score than I do. And even her platinum level is higher than mine, so high that I cannot say it out loud at this hearing.

I also understand that ionized platinum can cross the placenta. And significant levels of platinum are found in breast milk. I breast‑fed both of my daughters.

Since that time, my health has deteriorated. Some of my symptoms and diagnosis include asthma, photosensitivity, hives, throat swelling, and lupus, lung and bone pain.

My two children born before I had implants are very healthy, while Muffin and Stinkerbelle are constantly reacting as if they have multiple allergies when they have none. They endure bladder problems, photosensitivity, eczema, intense bone pain that wakes them up in the night screaming, lung pain, asthma, chronic pneumonia. Their lives and health have been forever altered.

As a mother who faces an unknown future for health consequences for herself and her young daughters, I ask you to vote no on this PMA application.

CHAIRMAN CHOTI: Thank you.

Good morning.

MS. SHEPPARD: Good morning. My name is Audrey Sheppard. I live locally and have no financial conflicts.

For four years, 1996 through '99, I directed the FDA Office of Women's Health. As a result of my professional involvement with silicone breast implants, I regard sharing my perspective an ongoing responsibility. I hold the agency and you in high regard and am optimistic about your making scientifically sound judgments.

My role at OWH, nearly a decade ago, requested by and partnering with the Center for Device Leaders, was to chapion and obtain full funding to conduct what became the critically important FDA rupture study. Its findings have resulted in a better understanding of the frequency of these devices rupturing over time.

You will be briefed ‑‑ and there has been reference to it already ‑‑ on the results. Suffice it to say that over time more than 65 percent of women in the study were found to have at least one ruptured implant and over 21 percent had silicone gel outside the capsule in one or both breasts. The latter finding is particularly concerning since the effect of silicone on the tissues and in development or progression of disease remains unknown.

After leaving the agency five years ago, I have advised and assisted women's health and other women's nonprofits and projects and from this vantage point will share three requests. One, follow the science.

Even the company's data, which you know will put on the best face, will not dispute a significant rupture rate nor other consequences of having these devices for years. These are not lifetime devices and, as such, without regular and too frequent resurgeries are not safe and effective, as intended.

Two, pay close attention to FDA's own documents and data. A number of documents on the CDRH Web site, including ‑‑ and I have the names, but you can find them. These themselves are damning information that is based on scientific research, decades of experience, tens of thousands of adverse event reports. And it also includes disconcerting photographs.

Please don't discount this body of material with the argument that the devices are much improved today. Make certain there is data to prove it.

And, number three, please believe your own eyes and ears when you see the dozens of sincere women whose health has been compromised standing before you. Of course, you will also hear from those who are highly satisfied. Their experience does not provide reason enough to open implants to wide use for augmentation, even by teenage girls.

To summarize, the health and well‑being of some of America's women and girls will be affected, even if they won't know it for years to come, by your decisions.

Thank you.

CHAIRMAN CHOTI: Thank you.

Good morning.

MS. GREEN: I'm Bettye Green. I'm the President of African American Women in Touch. And I am a breast cancer survivor. And I chose reconstruction after a mastectomy. However, I believe breast cancer patients deserve more information than they are getting.

Fortunately, there are many more options than there used to be for breast cancer patients. More than three out of four are eligible for lumpectomy. So relatively few women with breast cancer have a need to undergo a mastectomy in the last few years or in the coming years.

And, fortunately, women who undergo mastectomies have two other alternates to silicone breast implants. They can choose saline breast implants, which have a lower complication rate and are easier to remove when they break, or they can choose an autologous tissue transfer, a very popular procedure that moves tissue, in fact, from the abdomen or other areas to create a breast that is much more natural looking and feeling than a breast implant reconstruction.

Over the years, FDA panels have heard from some breast cancer survivors about the mental health benefits of silicone breast implants for mastectomy patients who want to reconstruct their breasts, but now that there are so many choices, do silicone breast implants offer benefits that are greater than other options, so great that they are more important than safety?

Research by Dr. Julia Roland of the National Cancer Institute and her colleagues found no difference in the quality of life of women who underwent lumpectomies, women who underwent mastectomies, and women who have had mastectomies with reconstruction.

Even more surprisingly, the women who had reconstruction felt their sex lives had been harmed more than mastectomy patients. If we look at the data presented by Inamed and Mentor, these findings make sense.

Most reconstruction patients require a lot of complications. They report more autoimmune symptoms two years after implants, such as joint pain and mental confusion, compared to before getting breast implants.

According to a study of women who had reconstruction five years earlier, most implant patients were no longer satisfied. In contrast, most of these autologous tissue transfer reconstruction patients remain satisfied. The implant makers remind us that their studies show that patients are satisfied.

But as a cancer survivor, a nurse, and a leader of a national group for breast cancer patients, I can tell you that most breast cancer patients don't tell their plastic surgeons that they are unhappy. They have been through cancer. Most don't like to complain about how they look now, especially in a study when being honest will not help them in any way and could potentially harm their relationship with their doctor.

I have another concern that nobody has mentioned and that is very important. There are very few African American women or Asian American women in the Inamed or in the Mentor study. For example, there are only six African American breast cancer patients in the Inamed core study and only five Asian American women.

This is a big problem because African American and Asian women are more likely to develop a cheloid scarring. This scarring tendency could potentially increase the risk of capsular contracture as well.

African Americans are also at an increased risk of autoimmune diseases. So it is essential that silicone gel breast implants not be approved until they are carefully studied on women of color.

In summary, research suggests that women who have had reconstruction after mastectomy do not have a higher quality of life than women who do not undergo mastectomy. Their sex lives seem to suffer more, not less.

Independent researchers found that the majority of implant reconstruction patients are not satisfied five years later. These findings are more credible than those funded by implant companies.

In one study, reconstruction patients were ten times as likely to commit suicide as mastectomy patients who do not undergo reconstruction. More African American and Asian American women need to be included in breast implant study, especially studies of breast cancer patients. Neither Inamed nor Mentor have studied enough women of color to determine if the risks are any different for them compared to white women.

Thank you so much for listening.

CHAIRMAN CHOTI: Thank you, Ms. Green.

Next? Yes?

MS. KUECK: Good morning. My name is Jana Kueck, and I'm a registered nurse from Branson, Missouri and a sister of an injured breast implant consumer. I've been a registered nurse for 21 years. My background includes labor and delivery, newborn nursery, and assisting new mothers as a former breast‑feeding educator. I have no financial relationship with the PMA sponsors, their products, and their competitors.

Numerous studies have found that breast‑feeding provides newborns with essential nutrition and improved resistance to infections. By impeding or preventing breast‑feeding, implants have become a public and pediatric health problem as they are essentially depriving newborns from these benefits.

According to the Institute of Medicine, any kind of breast surgery, including breast implant surgery, makes it three times more likely that women trying to breast‑feed will have inadequate milk supply or lactation insufficiency.

In a study conducted by Marianne Neifert and colleagues of the University of Colorado at Madison, women who had breast surgery were three times more likely to have lactation insufficiency than those that did not have surgery. The doctors compared the rate of weight gain of breast‑fed infants born to mothers who either did or did not have previous breast surgery. Mothers whose babies did not gain at least one ounce per day or required supplemental feedings with formula were deemed to have lactation insufficiency.

Interestingly, the women who had breast surgery through an incision in the nipple area or periareolar incision had a higher incidence of problems. Those women were more likely to suffer from insufficient milk supply.

I frequently have observed decreased milk production in mothers of breast‑implanted surgery. In addition, implanted mothers' infants also had difficulty latching onto the breast due to the firmness, usually caused by capsular contracture, even a mild contracture, from the implants.

We don't know how silicone breast implants affect what is in the mother's milk, but it is certainly worthy of more study. Recent research suggesting platinum in breast milk due to the platinum used as a catalyst in silicone breast implants concerns me a great deal.

Because of what is known and what is yet not known about the risk of implants on breast‑feeding, I am asking you to vote against the approval of Mentor's and Inamed's application. Voting against approval will support women's health and the health of precious newborns.

CHAIRMAN CHOTI: Thank you.

Next? Good morning.

DR. GOLDBERG: Good morning. Thank you for the opportunity to highlight a few scientific issues pertinent to the panel's review of gel implant safety.

I'm Eugene Goldberg. I direct the Biomaterials Center at the University of Florida. I have no financial interest in breast implants. I traveled here at my own expense.

My group has conducted research on the biocompatibility of silicone implants for more than ten years. In addition to my comments here, I have appended more information for you.

We published the only large cohort clinical evaluation of gel implants. This is a meta analysis of about 10,000 implants from 42 different papers. A high prevalence of rupture and additional surgeries was found. A plot of failure versus time showed 29 percent of rupture at 5 years and 70 percent of rupture at 17 and a half years. When the next slide comes up, you will see that.

One of every three women with implants required additional surgery within six years due to pain, hardness, disfigurement, or rupture. In an FDA‑NIH study using MRI plus explant surgery, Brown and coworkers confirmed our results. They found 69 percent rupture at 16 and a half years. And that falls directly on our implant rupture curve that is shown up there.

A Mentor consultant states that "Rupture is a critical safety parameter," but Inamed in a letter to the FDA says that rupture is "an unintended patient outcome." Frequent additional surgeries are truly also unintended, but both pose major safety risks.

Inamed now tells us that surgical damage is the leading cause of failure. If so, why aren't gel implants properly designed for normal surgical procedures? Inamed's 4‑year clinical results show still a high 10‑22 percent rupture, despite a presumably thicker shell with phenyl siloxane as a barrier. Short‑term rupture is actually not much lower than reported before.

Also note that crazing and cracking of phenyl siloxane coatings can occur after four to five years. And the barrier properties and strength may deteriorate as a result after five years. Four‑year clinical data are not adequate.

Finally, an increased risk for cancer of the lung, cervix, and brain is reported for gel implant recipients. It is simply not reasonable for Inamed to blame this on lifestyle with no scientific evidence. This is another potentially serious problem, and it must be resolved.

Thank you.

CHAIRMAN CHOTI: Thank you.

Good morning.

DR. WOOLEY: Good morning. I'm Paul Wooley. I'm Professor of Orthopedic Surgery, Immunology, and Biomedical Engineering at Wayne State University in Detroit. I have no financial ties with the sponsors or any of their competitors.

I would like to address the issue of latency and, in particular, the adjuvant effects of silicone. My group has been studying this for about a decade.

The hypothesis that we address is that silicone as a rather sticky substance, proteins, normal proteins of the body, can adhere to silicone. And minor conformational changes in the protein can result in the development of autoantibodies. And such autoantibodies may be significant in the pathology of connective tissue disease.

I have four publications in leading journals on the subject. And I would like to update the panel on the studies that we have conducted since they last met.

In our early studies, we demonstrated that silicone implantation in mice did result in autoantibodies, but those autoantibodies did not alter the disease process in either arthritis or lupus. However, our third study clearly demonstrated in a long‑term implantation in mice that disease was indeed exacerbated.

To take those studies to the human, we studied VP shunts in children and demonstrated adjuvant effects with the development of an autoantibody that was associated with an increased revision rate. However, the data that I have made available to you today is the first study that we have done in silicone breast implant material.

Paired samples of breast explant material, silicone explant material, and sera were made available to us from Dr. Fred Miller and Terry O'Hanlon at the NIH. These were provided in a blinded manner. We did not know which sera went with which breast implant, and we did not know the diagnosis or reason for the explantation.

Three of them it turned out the patients had either an autoimmune or a connective tissue disease. Three of them were clinically normal at the time of explanation.

We used a published and recognized method of removing the proteins from the silicone surface and we used the sera in a Western blot assay to assess whether the patient has a reaction against any of the adherent proteins.

Our findings were we believe quite significant. A novel 205‑kilodalton protein was removed from the surface of these explanted materials and was found to be immunologically active.

It turns out that this ‑‑

CHAIRMAN CHOTI: If you could sum up, please?

DR. WOOLEY: Yes.

‑‑ that this protein was associated with either MGUS or mixed connective tissue diseases. However, the antibody to that protein was also detected in patients who were clinically normal at the time of explanation. This antibody is not present in normal women.

Thank you.

CHAIRMAN CHOTI: Good morning.

MS. HEIDE: Good morning. My name is Terry Heide. And I'm reading a statement on behalf of a patient who couldn't be here today.

"My name is Nancy Reuben Greenfield, and I am sorry that medical issues have kept me away from delivering this speech personally. I want to thank the panel for giving me an opportunity present my support for silicone breast implants.

"First I need you to know that Inamed Corporation generously and compassionately sponsored my book, When Mommy Had a Mastectomy, which is designed to help parents and children through the trauma of breast cancer and the process of recovery.

"I am actually not one to talk about breasts in general, let alone in public. I have always been a tomboy. I got a sports bra because I had to. But along the way, I became a woman and a mother. And I will always consider nursing my children as one of the true highlights of my life.

"When I was 39, I got breast cancer and needed a double mastectomy. I wasn't sure what I would do after the mastectomies. I decided staying flat wouldn't suit me. And prosthetics are a great idea, but I have enough trouble finding my keys. So I decided on breast reconstruction, and I appreciated the fact that as a breast cancer survivor, I had the choice between silicone and saline implants.

"My plastic surgeon highly recommended silicone implants because his patients raved about their comfortability and he saw no differences in terms of their safety.

"When you have breast cancer and you have children, at some point you have to tell them. My children were five and seven at the time, and there was no book that could help me. So I decided to write one.

"Writing it was easier than getting it published. Even when I found a publisher, there were no funds available for the project. It was then that my publisher and I came up with the idea of asking the manufacturer of my implants if they would be interested.

"Based on my research, silicone has no worse or better effects on the body than saline. Based on my personal experience, my silicone implants are really comfortable.

"Frankly, I don't really understand the FDA research on silicone implants. They are already on the market for breast cancer patients. They have proved to be safe. And women are very satisfied with the results.

"Why should breast cancer be the determining factor on the use of silicone implants? It seems more like moral judgment on why people choose to have implants, rather than an issue of science and medicine.

"The choice to have silicone implants shouldn't be a consolation prize after breast cancer. Any woman who changes her breasts, for whatever reason, should have the option to use silicone implants.

"I ask you today to approve silicone implants for any woman who wants or needs them. Let all women be treated equally. Nancy Reuben Greenfield."

CHAIRMAN CHOTI: Good morning.

MR. GOOZNER: Good morning. My name is Merrill Goozner, and I am the Director of the Integrity in Science Project at the Center for Science in the Public Interest.

Integrity in Science seeks to focus public attention on the issue of how financial conflicts of interest are affecting the objectivity of the scientific process, especially through federal scientific advisory committees, such as this one.

While CSPI is largely self‑funded through its newsletter, the Integrity in Science Project I run receives additional funding from several foundations. None of these outside foundations have a particular interest in this issue or, I might add, in medical issues generally.

The Federal Advisory Committee Act prohibits people with conflicts of interest from serving on committees providing scientific advice. The logic behind this provision is that a person sitting in judgment of a body of evidence should not simultaneously be employed by an entity with a stake in the outcome.

The law allows for an agency to grant waivers if a scientist expertise is deemed necessary for the committee, which has happened in this case, a point I will return to in a second.

The law also requires that committees be balanced as to points of view, a recognition that even when there isn't a direct conflict of interest, a person's outside employment can influence their outlook on the questions at hand. The scientific literature is very clear on the impact of financial conflicts of interest on the outcome of science.

With this by way of background, allow me to address the makeup of this Committee. This Committee is smaller, yet similar, in makeup to the last committee evaluating the silicone gel breast implants. Its permanent roster includes Dr. Michael Miller.

According to your own statement this morning, Dr. Miller's institution has received $25,000 from Inamed, one of today's petitioners, for his role in producing an educational CD‑ROM about breast reconstruction surgery.

I have viewed video excerpts from that CD‑ROM. In it, Dr. Miller states, and I quote, "At this time, a number of good studies have been completed and there are others ongoing that show implants do not cause disorders, such as cancer or autoimmune diseases. Based on these studies, we are confident that breast implants are safe."

It would appear based on this evidence that Dr. Miller not only has a conflict of interest but has a point of view about the evidence he is about to hear regarding the safety and efficacy of these products.

The purpose of waivers is to allow scientists to serve when their expertise is deemed critical to the Committee's deliberations. In no way can Dr. Miller's expertise be considered unique. He is one of four plastic surgeons on this Committee, which brings me to the second issue of concern about this makeup.

The Federal Advisory Committee Act requires that committees be balanced. Eighteen months ago, after the last committee voted nine to six in favor of allowing the silicone gel breast implant on the market, with all four plastic surgeons on the committee voting in favor, the chairman of that committee, Dr. Thomas Whalen, wrote then FDA commissioner, Mark McClellan, decrying the committee's lack of balance. Specifically, he noted, "Even in academic settings, plastic surgeons may stand to increase their own income with the use of these devices."

Whether one agrees with that statement or not, the fact is that the number of plastic surgeons on this committee is double the number of physicians who treat the diseases that might arise from the use of these devices. Where is the balance?

The Center for Science in the Public Interest is extremely disappointed that the FDA chose to overlook the conflicts of interest and has created an unbalanced panel to evaluate the evidence on this issue. The FDA has again created a situation where the final vote will be clouded by the perception that some members had conflicts of interest that my have influenced the vote.

CHAIRMAN CHOTI: Thank you.

Good morning.

MR. COMPTON: Good morning. I'm Phil Compton, and I'm Community Organizer for our Florida Consumer Action Network, a grass roots consumer organization with more than 40,000 members statewide. I come here today with no financial ties to either sponsor or any of their competitors.

Following the October 2003 panel, the chairman of the advisory panel, Dr. Thomas Whalen, took the highly unusual step of writing a public letter to then FDA commissioner Mark McClellan. This is the first time that a chairman of an FDA advisory committee ‑‑ and there are literally hundreds of them spread over the 5 operating centers of FDA ‑‑ has written such a public letter in at least a decade. This letter was reported on the front pages of major newspapers across the country.

For the new members of the panel, here is what Dr. Whalen wrote, "Dear Dr. McClellan, on October 14 and 15 of this year, I chaired the General and Plastic Surgery Devices Advisory Panel in Gaithersburg, Maryland for consideration of a PMA by Inamed Corporation for silicone gel breast implants.

"As I am sure you are aware, the panel voted nine to six that this PMA was approvable, and the matter is now under consideration for action at the CDRH. I write to express as the panel chair my very strong reservations concerning this vote, having thoroughly reviewed the PMA, heard my scientific colleagues on the panel, as well as the presentations of Inamed and the FDA, and having intently listened to all of the over 100 individuals who gave public testimony.

"At its essence and as is mandated by federal code, the mission of an FDA panel and then the FDA itself acting upon the panel recommendation is really elegantly simple: To judge that the company bringing the PMA before them has demonstrated with reasonable assurance that the product under consideration is both safe and effective. Effectiveness was demonstrated and is almost self‑evident.

"Long‑term safety, the concern that prompted the removal from the market 11 years ago, was clearly not demonstrated. And to approve this device poses threats to women that are clearly unknown.

"In my opinion, there is at least one facet of long‑term danger that was established during the panel: Specifically the obscuration of surrounding normal breast tissue to mammographic detection of breast cancer. The reoperation rates and other local complications from silicone leaking outside the breast area have also been established by FDA scientists and are not minor considerations for a cosmetic device.

"Moreover, despite the sophistication of the Institute of Medicine's report, all of what was considered by them reflected low‑quality data in the age of evidence‑based medicine.

"It is incumbent upon the FDA to demand that the manufacturer establish in a rigorous prospective, controlled study that these devices, despite their established breakage and leakage rates, are safe in the long term. If that is deemed to not be feasible for the company, then they should abandon pursuit of approval. However, the company's track record suggests that they are capable of such research but have not been sufficiently motivated to complete it.

"The plethora of approval conditions that had my head spinning during panel deliberations is proof that even those who voted the PMA as approvable are deeply concerned about the lack of long‑term safety data on this product. What will motivate the company to follow these FDA requirements?

"Most upsetting was when an FDA official admitted, at my pressing, that there is little, if any, remedy for the FDA if demands to demonstrate long‑term safety are not carried out by the company.

"I need not point out to you in your position what the term 'FDA‑approved' represents to our citizenry. Once this horse is out of the barn, indeed for a second time, there will be no recourse.

"I have the utmost respect for my colleagues on the panel, one and all. This most assuredly includes the four well‑respected and knowledgeable plastic surgeons. Certainly, it was essential to include board‑certified plastic and reconstructive surgeons when considering a PMA on breast implants.

"On the other hand, it serves the reputation of the FDA in general and the standing of the panel process, in particular, exceedingly poorly to have had all of the plastic surgeons vote the PMA as approvable on such a close vote. Even in academic settings, plastic surgeons may stand to increase their own income with the use of these devices. To cite a worn aphorism, it just does not play well in Peoria.

"In closing, I must add that the issue of medical care of women who suffer complications from these implants is extraordinarily troubling. Costs for removal of these implants and for extra‑capsular silicone can be enormous and are very rarely covered by a health plan. This is a public health issue of no small import that must be addressed should the FDA second this misguided panel decision.

"I have been honored to be a part of the General and Plastic Surgery Devices Advisory Panel these past few years, and have been extremely impressed by the devotion and professionalism of those in your agency.

"I regret that the final chapter of my FDA experience was this one and implore you and Drs. Feigal and Witten to not approve this PMA. I would be delighted to provide any further information if you desire it.

"Sincerely yours, Thomas V. Whalen, M.D., Professor of Surgery and Pediatrics."

Now, there are two questions each of you should ask. What did the Center for Devices and Radiological Health do to find out what happened here and to correct it? If FDA did nothing, then how can the agency expect to have an impartial advisory committee meeting?

Thank you.

CHAIRMAN CHOTI: Good morning.

DR. PARISIAN: Good morning. I'm Dr. Suzanne Parisian. I am speaking on behalf of Pro‑Choice Alliance for Responsible Research. I formerly was a chief medical officer for Office of Device Evaluation, Center for Devices and Radiological Health at FDA. I'm a physician. I'm board‑certified in pathology. And I'm author of FDA Inside and Out.

Thank you for considering my testimony. I have no conflicts of interest with any of the applicants or their competitors.

When FDA denied Inamed's marketing application in 2003, it followed by releasing a guidance document requesting ten years prospective data for primary augmentation, reconstruction, and revision populations.

FDA provided methods for mechanical testing, requested rupture rates, and longer clinical studies, addressing areas which FDA indicated were critical to the assessment of safety.

FDA expressed concerns that implants were rupturing at unacceptably high rates, that longer‑term health risks were still unknown, and silicone's effect on the body was not yet fully studied.

Liquid silicone injection has not been found to be safe by FDA in other application reviews. However, industry routinely dismisses FDA's requests for long‑term data and continually ignores all the safety concerns.

On average, women begin to report problems with their breast implants at seven to ten years after implantation. Therefore, three to four‑year studies with clinical data are not adequate to assess safety. We still do not have the adequate long‑term safety data for silicone breast implants. The manufacturer's application should be denied.

FDA first requested this safety information for silicone breast implants in 1988 for products that had already been on the market 20 years. Instead of science, valid data, and a concern for women's health, FDA continues to be met with well‑financed and well‑organized resistance. If FDA cannot compel PMA sponsors to provide the adequate long‑term safety data for silicone breast implants before PMA approval, it will never be obtained.

Improved manufacturing practices, quality controls, and informed consents have been instituted through the efforts of CDRH's staff. I know that. And this is for both the saline‑filled and the silicone gel breast implants.

I know that sponsors tell FDA that the women are lost to follow‑up for long‑term data because they're too embarrassed to talk about their silicone breast implants with the companies. Yet, these same sponsors can find these women in order to finance their breast implants and make payments or they can suddenly locate data in Europe that they didn't have before.

Although there are many inadequacies in these PMA applications, time only permits me to make four brief and important points. First, neither Inamed nor Mentor have come up with reliable safe rupture rates. They have come up without good methods to detect rupture rates. And their data does not reasonably predict the safety profile for each device over its lifetime.

According to the FDA analysis of the industry data, three‑quarters of implanted women will have at least one ruptured implant within ten years of receiving the devices. Specifically, FDA has estimated that up to 93 percent of breast cancer reconstruction patients should receive at least one broken implant. They will have, will expect to have, not receive.

Second, FDA should have the PMA sponsors obtain information about the children. As we have been hearing, the children have been left out of the guidance document. And we need further information about what happens to the children born to women with silicone breast implants. No woman would want to have a cosmetic surgery and then hurt her children. And these products will be aggressively marketed to women, young women. Now implants are being put in women younger than 18 years of age.

Third, implants can obscure mammographic imaging by hiding the breast tissue. MRIs have been set as an alternative technology to screen these women, but they're not always accurate. MRI doesn't always detect rupture in these women. And there's conflict between rupture and explants.

Additionally, it has been very misleading to the public to imply that MRI facilities are trained, willing, or can be reimbursed for these types of studies. The average cost of an MRI is $1,890. So a recommendation that women receive MRI is not inconsiderate in terms of expenses. And also, young women do not routinely receive any kind of imaging.

Fourth, FDA's approval, as I know, is the gold standard for the American consumer. After the 2003 FDA panel meeting, FDA determined that silicone breast implants were unsafe. The long‑term effects still have not been adequately addressed by either sponsor as they continue to ignore FDA guidance. You still do not have that safety data that you thought was necessary 20 years ago. So please do not recommend approval.

Thank you very much.

CHAIRMAN CHOTI: Good morning.

MS. BAEKE: I am Suzanne Baeke. I am a registered nurse, patient educator specializing in plastic surgery. I have no financial ties with any of the breast implant manufacturers.

I chose to have breast implants seven years ago. Three years later, my life with silicone gel breast implants would be best described as the roller coaster ride from hell.

Each day brought with it new horrors: fevers up to 103, chills, memory loss. Concentrating on everything became a problem, hair loss, repeated bladder infections, zero sex drive, dry mouth, severe joint pain, painful feet, and crippling muscle spasms to the point where I had to have three deep tissue massages per week.

The mood swings were crippling, not just for me but my entire family. At times I wished I were not alive. I suffered the chronic fatigue, yet suffered from insomnia. I would at times have to pull into a parking lot and shut my eyes for what I thought would just be a minute but turned out to be 45.

I was evaluated by my rheumatologist at the Mayo Clinic for chronic fatigue syndrome. MS, fibromyalgia, ankylosing spondylitis were all considered. Members of the Committee, I would not have wished my life on anyone, but I refuse to give up. I refuse to live this way. And I was on a mission to find out what was wrong with me.

I bought every product on late‑night television that promised to fix me. Eventually I found an endocrinologist, Dr. Bernard Rice. He performed on me the most comprehensive evaluation I had ever witnessed. Eventually he took me by the hand, took my husband, and said, "Your wife needs hormone replacement. The fact that you are still married is incredible. Most men get out when things get this bad."

Dr. Rice is one of the pioneering investigators in the gradual but debilitating effects of hypo‑ovarian syndrome. Call it premenopause if you wish. All women begin to suffer the effects of low ovarian testosterone production early in life, progressing until full menopause. For me, the hysterectomy with an oophorectomy sped up this insidious process.

Distinguished panel, I am here to set the record straight. It is no coincidence the symptoms of which I suffered are identical to many of the women testifying today. I submit that silicone implants have been ridiculously maligned when more likely the culprit is the low testosterone levels in the pre‑menopause and menopause patient. With expert estrogen and testosterone replacement, all of my symptoms immediately reversed. And I still have my silicone gel implants.

To the National Organization of Women, I challenge you. If your motives are truly honorable, consider that you may be wrong. Read my lips. The real problem afflicting millions of women is not silicone gel implants. It's, rather, inadequate hormone replacement therapy.

Thank you.

CHAIRMAN CHOTI: Good morning.

DR. BAEKE: My name is Dr. John Baeke. I am a plastic surgeon with extensive knowledge regarding silicone gel breast implants. I have no conflict of interest.

Second slide. Please review my data carefully, paying close attention to my low complication, reoperation, and zero deflation rates. I provided full handouts out in the hallway for each one of the panel members. And I invite you to please pick up one.

After the 2003 hearings, I was disheartened by the dearth of testimony supporting the elective cosmetic surgery patients. I will not be shy in standing up for these women. Organizations like NOW too often portray women desiring breast enhancement as bimbos. Shame on you. The cosmetic patient is typically careered, in her 30s, seeks multiple opinions, is well‑versed on the subject, and on average requests only one and a half cup size increase.

Slide. Surgeons performing breast augmentation do so not out of financial motivation. Those guys can be found next door at the Botox hearings. If we were purely profit‑motivated, cheaper, wrinkle‑prone saline implants would suffice. As plastic surgeons, we are committed to providing women with the most beautiful breasts possible. And that requires silicone implants. If not for that simple fact, we'd all go home.

Slide. How extraordinarily hypocritical, if not insulting, to allow silicone implants for the cancer survivor but not for the cosmetic patient. To the mastectomy patient, the message is, "You're going to die of a disease anyway. So who cares?" To the cosmetic patient, the message is, "Your plight is not to be taken seriously." It is arrogant for anyone to believe a small‑chested woman is not experiencing real pain because of her developmental misfortune.

Slide. What a double standard for feminist groups to promote a woman's right to choose when it comes to issues of abortion but not to embrace that same freedom when it comes to silicone implants.

Slide. Why is mere dozen‑word warning appropriate for cigarettes; yet, for silicone implants, the bar is set higher?

Slide. Shame on the naysayers for the hypocrisy of condemning Inamed for presumed insufficient data. Remember, the core and adjunct studies that criticized were designed with the oversight of the FDA. At the same time, these individuals have become masters of the melodrama, presenting volumes of purely anecdotal, nonverifiable, oft exaggerated quips before this esteemed Committee without ever undergoing any type of similar scientific scrutiny.

Does it stand the test of logic that surgically removing implants would lead to sudden improvement in symptoms when this is supposed to be a disease caused by systemic‑wide dissemination of silicone?

Slide. One simple answer to this dilemma should satisfy all. Legislate a standardized, comprehensive informed consent. Require its usage by all. Then trust the sanctity of the patient‑physician relationship.

Slide. Since no one else will stand up and say it, I will. Companies like Inamed should be commended for the millions they have invested in research and development. The modern‑day silicone implant is safe to the satisfaction of medicine and science alike. Thank you, Inamed.

MS. CUMMINGS: Good morning. Ladies and gentlemen, my name is Arlene Nicole Cummings. I came here at my own expense today to tell you about how breast implants have affected me.

At the age of 12, I had a breast tumor removed from my right breast. This left me with an asymmetry problem that only got worse as I got older and had my children.

Fixing my breast was something I had thought about for years. After I was done having my children, I felt the time was right. I did a lot of research online and found a great deal of information but nothing personal. This is what prompted me to start implantinfo.com back in 1998, after my own surgery.

Implantinfo is now the largest community Web site for breast augmentation patients where women can research the good and the bad about breast implants and go through photos and stories of thousands of other women.

I am here today primarily because I am a satisfied breast augmentation patient. However, I never had the option of choosing silicone back in 1998. After years of talking to women and doing my own research, I now believe silicone is a superior product in many ways. If I had the option today, I would choose silicone over saline.

On my Web site, I have corresponded with countless women who, for many reasons, probably should have had the silicone option but did not. They were denied silicone implants, had an unsatisfactory result with saline, and then had to have a second surgery to replace their saline implants with silicone. So they actually had to have two surgeries to get the result they wanted the first time.

I am also aware of the frustration surgeons feel because they cannot give a patient what they know in some cases will produce a better result for them.

The risk of a second surgery in my opinion is far greater than any silicone implant would have posed. Ironically, breast cancer patients already have compromised immune systems but for the most part can receive silicone implants.

Are they at less of a risk of the supposed risks of silicone breast implants? I believe silicone implants provide a far better result for reconstruction. If these patients get better results with silicone implants, shouldn't they be available to all of us? Women along with their surgeons should be allowed to choose silicone or saline. We are neither ignorant nor shallow, and we are not seeking breast augmentation without informed consent.

We have researched the procedure for years. The average age of a woman on my Web site is 34. Most of us are married with children and just want to get back what we lost after pregnancy and nursing.

I believe in informed consent. And women should know all of the risks. But in the end, after we review that information, let us decide along with our surgeons silicone or saline.

I've received dozens of e‑mails from women who wanted to be here today in person but could not for many reasons. There are thousands of women like me on implantinfo.com. And I encourage you to come to the Web site to read more about us and to give us both the choice of silicone and saline.

Thank you for your time.

CHAIRMAN CHOTI: Thank you.

MS. COLOMBO: Good morning. My name is Michele Colombo. I am 36 years old, married, and I have one child. And I come here at my own expense.

For many years, I was dissatisfied with the size and appearance of my breasts. I am a very self‑confident and educated person, but I have always seriously considered improving my appearance by undergoing breast augmentation.

I researched breast augmentation for approximately five years, including reading the FDA Web site as well as other resources on the internet. In doing so, I satisfied myself that silicone implants are a safe alternative for my breast augmentation.

Due to a vocal minority in the early 1990s, silicone breast implants were banned for sale to most ordinary people, like me, in the United States. If I lived in Europe, I could get silicone breast implants without any question. If I traveled to Europe, I could get silicone breast implants and I could come back to the U.S. and live here with them, even though they're unavailable here. If I had breast cancer, I could get silicone breast implants, perhaps because those with breast cancer are less prone to the purported risks of silicone breast implants.

What's more, if I were a man, I could get silicone testicular implants. And if I required shunts for medical reasons, it would also be made of silicone.

Fortunately for me, in an ironic way, when I was seeking breast augmentation options, I was able to qualify for silicone implants because I have a congenital deformity. What does not make sense to me is that silicone breast implants have been shown in numerous studies to have no more long‑term health risks than saline breast implants and other silicone devices.

Despite the fact that the FDA up until now has allowed some people to get silicone and not others, I don't understand why someone else can decide that they are safe for me or for a cancer patient but not safe for someone else. In other words, a woman can make a decision about safety of breast implants if they have cancer but not if they simply want to improve their physical appearance.

I am here to tell you that the benefits to women, regardless of whether they have cancer or some other arbitrary qualifying factor, are equal. My life has improved dramatically since I had my surgery last year. My sense of self has improved. And it has affected aspects of my life too numerous to mention. I had a child after my breast augmentation with silicone breast implants and breast‑fed him successfully.

I think it is time to reevaluate the true motivation for the ban on silicone breast implants. The fact that breast cancer patients may obtain them and cosmetic patients cannot exposes the true reason for the ban. What is at stake is a moral judgment, rather than a medical one.

If my breasts are completely deflated from breast‑feeding, weight loss, or age, improving my appearance with breast implants is deemed unacceptable because it would be for vanity. If I had a mastectomy, it would be acceptable because it could be justified as medically necessary, although many women choose not to get implants after mastectomy.

The difference is a moral one, not a medical one. I don't believe the FDA is the right organization, if any, to determine what is morally appropriate to do to our bodies. If the FDA is going to ban silicone implants based on unacceptable risk, I think it is time to ban all medicines which have side effects.

Why is my psychological desire to improve my appearance less important than the desire of others to curb their appetites through approved weight loss drugs, reduce heartburn, stop hair loss, et cetera? The truth is it's just as important.

I urge you to remove the ban on silicone breast implants and let women make informed decisions about their bodies the way millions of people do every day with countless other devices and medicines approved by the FDA.

Thank you for your time.

CHAIRMAN CHOTI: Thank you very much.

And at this point, we'll take a break of about 15 or 20 minutes. Let's resume promptly at 10:30. Thank you.

(Whereupon, the foregoing matter went off the record at 10:10 a.m. and went back on the record at 10:39 a.m.)

EXECUTIVE SECRETARY KRAUSE: I think we are about ready to start. AnnMarie is here. Okay. I am going to turn the meeting back over to Dr. Choti.

CHAIRMAN CHOTI: Good morning. May we have our next public speaker, please? Remember, you have three minutes. And, just to remind you again, the yellow light comes on with a 30‑second warning. And you need to stop by the time the red light is on.

MS. CORBETT: Actually, I'm representing an organization.

CHAIRMAN CHOTI: Okay. So five minutes.

EXECUTIVE SECRETARY KRAUSE: Are you Christianne Corbett?

MS. CORBETT: Yes, I am.

EXECUTIVE SECRETARY KRAUSE: Okay.

MS. CORBETT: Yes. Good morning. My name is Christianne Corbett. I am the Program Coordinator at the National Council of Women's Organizations, NCWO. NCWO is am umbrella group for 200 women's groups. And I am speaking on behalf of the over ten million women nationwide that NCWO represents.

NCWO is very concerned about the safety of medical products used by women. The key question for this FDA advisory panel is whether silicone gel breast implants are safe, whether the benefits outweigh the risks.

In my testimony, I will focus on what we know and don't know about long‑term safety. We know from hearing testimony of the women at the 2003 panel meeting and again today that many of these women were very happy with their implants for the first few years. But after seven or more years, especially after their implants broke and started to leak, many women reported serious problems.

Local complications are the best established problems. These complications can be short‑lived, like most infections, or can be devastating. Chronic pain is very difficult to live with.

Having breasts that are hard as rocks is not a goal for most women. And if things go wrong and implants have to be removed, then what happens?

I have some photographs that I want to share with you. The photograph up right now is a photograph of a 29‑year‑old woman who had her implants removed after 7 years. She had capsular contracture that was so painful that she decided to have her implants removed. This photograph is from the FDA website.

Here is another woman ‑‑ you can go to the next slide ‑‑ who wasn't so lucky. This woman's ruptured implant had leaked into her healthy breasts. And when the silicone was removed, that is all that was left of her breasts.

Now let's look at some long‑term studies of diseases. The National Cancer Institute looked at thousands of women who had implants for at least eight years. They found women with implants were twice as likely to die from brain cancer, three times as likely to die from lung cancer, and four times as likely to commit suicide compared to other plastic surgery patients.

FDA's scientists did the best study of the health of women with ruptured silicone implants. All the women in their study had breast implants for at least six or seven years. So some had implants that had been leaking for several years. They found that women with implants that leaked outside the scar capsule were significantly more likely to report fibromyalgia and several other painful connective tissue diseases.

Dow‑Corning paid for another study on ruptured implants, referred to as the Danish study in the FDA review that was provided to you. Unfortunately, the Danish study included only 23 women with implants that leaked outside the scar capsule. They found that those women had more pain and other problems than women whose implants were not leaking, but because of the small sample size, those differences were not statistically significant. The study is not conclusive because the number of women with extracapsular leakage is much too small.

Implant makers often say that there are more than 100 studies of women with implants and that these studies prove that implants are safe. When they say this, they tend to ignore the studies that don't agree with them, which tend to be the studies of women who had implants the longest, such as the FDA and the NCI studies.

Most of the studies that the implant makers quote as proving safety were funded by Dow‑Corning. Almost all of the studies in the often‑quoted Institute of Medicine report, including the Mayo Clinic study and the Harvard study, were funded by Dow‑Corning. And, like the Danish study I mentioned, they tend to have rather small samples. And most studied women who had implants for a short period of time. For example, the Mayo Clinic study included only 749 women with breast implants, and only 375 of them had had implants for more than 7 years.

Autoimmune diseases take years to develop and be diagnosed. And the sample would have to be larger to adequately study diseases that are so rare in young women. You don't have to take my word for it. The authors point that out themselves.

Listen to the testimony you will hear from the women today. It took years for them to develop diseases after getting their silicone implants. First, they had symptoms that they didn't take very seriously. When they were tired or their joints hurt or they had trouble concentrating, they thought that perhaps they just weren't getting enough sleep or they were working too hard.

Those are the same symptoms reported by Inamed in their patients who had implants for only two years. They aren't sick or diagnosed with diseases like rheumatoid arthritis, but it will take at least a few more years to find out if they will be.

One more thing is that almost all of the women in the core studies are white. Women of every racial group got breast cancer, but only six African American women and five Asian American women are in the Inamed reconstruction study. Race is an important issue because African American women are more likely to get autoimmune diseases than white women.

In conclusion, not enough research has been done on large diverse samples of women that proves that silicone breast implants are safe in the long term. Because of this, on behalf of the National Council of Women's Organization and the ten million women NCWO represents, I urge you to vote against the approval of silicone breast implants.

Thank you.

CHAIRMAN CHOTI: Good morning.

MS. SILVERMAN: Good morning. My name is Virginia Silverman. This is my daughter Eve. She is six years old. I am from Laguna Niguel, California. Inamed paid for my flight here today. I am here today to talk about choice, a woman's inherent right to choose what is right for her body.

In September 2001, just days after September 11th, I was diagnosed with early‑stage DCIS breast cancer. After educating myself about the aggressive nature of my cancer, my treatment options, recurrent statistics, and my potential for complete cure, I chose to have a bilateral mastectomy. As a result of my aggressive treatment choice, I was cured of the disease with no need for chemotherapy, radiation, or tamoxifen.

To expedite my recovery, I chose to initiate my breast reconstruction during the initial cancer surgery. When I awoke from the operation, the cancer had been excised and saline tissue expanders had been inserted.

During the 12 weeks following my mastectomy, saline was injected into my expanders each week. As more and more saline was injected, the saline implants proved to be extremely uncomfortable. The water was hard inside its containers. And I experienced my breasts as inflexible, immovable objects on my chest. With every movement of my body, I was acutely aware of the foreign objects residing beneath my chin.

Finally, my tissue extension phase was over. And I received my permanent silicone implants. I chose the Inamed silicone gel implants because I was confident, then and now, after exhaustive research of their safety.

It has been three and a half years since I chose to cure myself of breast cancer and place silicone gel implants inside my body. Compared to the rigidity and discomfort of the saline implants, my silicone implants are comfortable and pain‑free.

While the saline implants were annoyingly inflexible and hard, my silicone implants are pliable and comfortable, contouring to both my body and my clothing. They even move when I dance and exercise.

As the Vice President of Marketing for Lindora, America's leading medical weight management company, it is my responsibility to be an active advocate on behalf of women's health issues.

I stay abreast of the most current medical advancements leading to healthier, happier lives for women everywhere. After over a decade of diligent research showing virtually no health issues with the product, I believe silicone gel implants should be available to all women, whether they are breast cancer survivors or not.

In conclusion, on behalf of myself, my six‑year‑old daughter Eve, who is with me today, and all women who are choosing to enhance their lives through breast reconstruction or enhancement, I urge you to approve the use of silicone gel implants for wide consumer use.

We have a right to decide what is right for our own bodies. I chose to live by electing my double mastectomy. I chose to live well by selecting silicone gel implants. I choose to be here today to encourage you to give women here in America the opportunity to choose for themselves which implant is right for their bodies.

Thank you very much for your consideration and your time today.

CHAIRMAN CHOTI: Thank you.

Yes? Next? Good morning.

DR. MAHARAJ: Good morning. I'm Dr. Susan Maharaj, and I am a professor of chemistry. I have no conflict of interest. Today I am presenting the results of Maharaj 2004, Maharaj and Lykissa 2004, and Lykissa and Maharaj 2005.

Next slide, please. Maharaj 2004. The results show that high levels of platinum are present in silicone breast implant gel, shells, and in the corresponding capsular tissue of women exposed to silicone breast implants. The gel and shell platinum values in this study are much higher than reported by manufacturers. Platinum tissue concentrations in women exposed to silicone breast implants are higher than in tissue samples of women not exposed to these devices. And, in fact, the values do not overlap.

Next slide, please. Maharaj and Lykissa 2004 and Lykissa and Maharaj 2005. Mean platinum concentration in whole blood and urine samples of women exposed to silicone breast implants was higher than in control subjects.

Mean platinum concentration in whole blood and urine samples of children conceived after their mothers were implanted was higher than in children conceived before their mothers were implanted.

Next slide, please. Mean platinum concentration in hair, nails, and sweat samples of women exposed to silicone breast implants and in children conceived after their mothers were implanted were higher than that of the general population and higher than in children conceived before their mothers were implanted.

Mean platinum concentration in breast milk samples of women exposed to silicone breast implants was much higher, about 100 times higher, than samples from women not exposed to these devices.

Next slide, please. Mean platinum oxidation states in explanted silicone breast implants occur mainly in the +2, +4, and +6 valence states. This is a very important point. Manufacturers are claiming and FDA believes that platinum is in the zero valence state. Mean platinum oxidation state in whole blood samples of controlled subjects was mainly in the zero oxidation state.

Next slide, please. Mean platinum oxidation states in whole blood and urine samples of exposed women were mainly in the +2, +4, and +6 oxidation states. Mean platinum oxidation state in whole blood samples of children conceived by mothers after implantation and in a brain tissue sample of an exposed individual were in the zero, +2, and +4 oxidation states.

Next slide, please. In conclusion, my main three points are as follows. Number one, the platinum concentration in gel and shell material of silicone breast implants is actually much higher than reported by manufacturers.

Number two, the platinum concentration in many different types of samples is consistently higher in women exposed to silicone breast implants than in non‑exposed individuals and is higher in children conceived after implantation than in children conceived prior to implantation.

And, number three, silicone breast implants contain highly reactive forms of platinum.

Thank you very much.

CHAIRMAN CHOTI: Thank you.

MS. WOLF: Good morning. My name is Carolyn Wolf. I live in Virginia, and I came here at my own expense. I have no conflicts of interest.

In 1972, after subcutaneous mastectomies, I had reconstruction with the newest, best construction, silicone implants, that were safe and would last my lifetime.

There were no problems in the beginning. By the seventh year, burning, blister‑like growths started on my neck and boil‑like growths on my forehead. Sixteen years after, three days were spent in ICU because of severe burning chest pains.

By the 21st year, my family had noticed a change in personality. And I had noticed cognitive changes. By the 25th year, though a non‑smoker, I was coughing up hard, greasy, gold‑colored plugs. X‑rays showed chronic obstructive pulmonary disease.

A military plastic surgeon checked me every year. I never connected my problems with the implants until my left breast capsule collapsed 28 years after implantation. MRI showed both implants extensively ruptured. Shortly thereafter, a glob of silicone moved from my breast into my armpit, leaving an elongated swelling in its path. There was excruciating pain.

In April 2000, vision was lost in my left eye for 45 minutes. Pain continued in that eye until a long, stringy glob came out of it several weeks later. Two similar strings were exuded from my left ear in the 30th year.

Explantation performed in 2000 showed the left implant measuring only four centimeters. The scar capsules surrounding the implants contained chronic inflammation and foam cells containing silicone. Few women had implants as long as I.

I have been diagnosed with silicosis, rheumatoid arthritis, connective tissue disease, Raynaud's, and silicone‑induced MS‑like syndrome with neuropathy of the extremities.

My brain MRI shows more than 20 lesions. My silicone level is .11, more than double what is normal. My platinum level is 20 times normal. Silicone continued to be exuded from my nipples until simple mastectomies to remove painful calcified tissue was performed six months ago.

National Cancer Institute has conducted the only study of women implanted for more than eight years. That found women are much more likely to die of brain and lung cancers and suicide. If implants are so safe, make sure that manufacturers prove that it is safe.

The studies you will hear about tomorrow do not prove that. The women studied were not implanted for more than ten years. You have no control over the advice given or not given by plastic surgeons. What happened to me will eventually happen to thousands of women with silicone implants. And please do not inflict this on another generation.

CHAIRMAN CHOTI: Thanks.

MS. KEELING: My name is Marlene Keeling. I am President and founding Director of Chemically Associated Neurological Disorders, or CANDO. I have paid my own way here because of my concern over toxic and hypersensitizing chemicals that I am convinced are leaking or bleeding from implants into not only the bodies of women but, even more worrisome, their children born after implantation.

I was implanted with McGhan double lumen breast implants in 1978. I had my ruptured implants removed in 1994, after I became convinced that my implants were causing my swollen lymph nodes, hair loss, memory loss, overwhelming fatigue, peripheral and demyelinating neuropathy. I was perfectly healthy before I got implants, got sick, had my implants and scar capsule removed in block and not replaced, got better.

When tested for platinum six years after explantation, my urine was found to contain 36 parts per billion per liter of urine. Platinum was found to leak from my implants. And platinum was also found in my hair, nails, sweat, and blood.

The ionization or speciation of my platinum was +2 and +4. Dr. Joseph Bubinak, a board‑certified hematologist and medical oncologist, testified before a breast implant advisory board in 2002 regarding his experience with the chemotherapy agent cisplatin.

Dr. Bubinak reported that he was astounded to learn that the catalyst used to manufacture the silicone for breast implants was platinum chloride, a highly reactive molecule and precursor to the chemotherapy agent cisplatin. He stated that some breast‑implanted patients have the same systemic complaints and side effects as cisplatin‑treated patients, including fatigue; hair loss; loss of short‑term memory; rash; and other allergic reactions; respiratory system problems; and peripheral neuropathy, which is sometimes disabling.

Dr. Bubinak stated that the migration of reactive platinum alone could explain capsule formation and tells the world that the chemicals in breast implants are not inert.

Can you go to C? Dr. Maharaj has presented data from CANDO's research project number 1 here today. Based on this research, it was determined that urine was the least invasive, best method to test for platinum levels in the body.

CANDO's research project number 2 has now tested the urine of over 50 breast‑implanted women and their children born prior to and after implantation. I have copies of this raw data, which I can give to the panel today.

Previously in a written submission, I gave the panel a copy of the CDC's platinum urine study in the general U.S. population of over 1,000 people. And not one of them had over the level of detection of 0.04 parts per billion.

To quickly recap, the results of the raw data presented today, one child born after implantation tested over 300 parts per billion. One woman tested over 200 parts per billion 11 years after explantation. And nine women and one child tested over 100 parts per billion.

The panel was also given a copy of Dow‑Corning's 1996 letter notifying the EPA of substantial risk to their platinum catalyst used in breast implants. Ionized platinum is on the list as being a suspected neurotoxicant and immunotoxicant.

Mentor's most recent FDA‑approved product insert makes the following statement, "Toxicity studies are currently in progress by various research facilities, universities, government agencies, the medical community, and the medical device industry. Some of these studies are conducted in animal models to determine potential immunotoxicity and autoimmune issues related to silicone materials. There is the potential that in the animal models being studied, immunotoxicity may result."

I submit it is not safe enough for the FDA to simply say it is not known if a small amount of silicone may pass from the silicone shell of an implant into breast milk. If this occurs, it is not known what effect it may have on the nursing infant. We must protect our future generation, who cannot make a choice.

Thank you.

CHAIRMAN CHOTI: Yes? Good morning.

DR. MAO: Good morning. My name is Jeremy Mao. I am Associate Professor of Bioengineering and Cell Biology at University of Illinois. I come here today with no financial ties to either the sponsor or any of their competitors. My testimony today will be related to mechanical testing of silicone breast implants.

I have reviewed the scientific and regulatory literature extensively on mechanical testing of silicone breast implants. After review, it seems that there is a shortage of data, mechanical testing of implants in simulated in vivo environment.

The in vivo environment surrounding silicone breast implants is complex and consists of fibrous capsules, many cytokines, protolytic enzymes. The local chemical and physical environment, such as pH and temperature, may also affect the outcome of mechanical testing.

There is experimental evidence that the in vivo environment weakens silicone gel breast implant shells over time. Several articles published in Plastic and Reconstructive Surgery and other journals have demonstrated the need for performing mechanical testing in simulated in vivo environment.

Silicone breast implants rupture for a variety of reasons. The complexity of tissue‑borne mechanical stresses on implants is a result of tension, compression, and shear stresses. In most previous mechanical testing studies, only uniaxial mechanical forces are applied. This represents only one of the multiple dimensions of mechanical stresses in vivo.

Multidimensional forces may be used to simulate mechanical testing of breast implants to adequately simulate the conditions in vivo in the patient's body.

ASTM International has several guidelines for testing silicone breast implants, such as tensile strength, ultimate elongation, and fatigue life. However, in 1989, Plastic Surgery Subcommittee members stated that the tensile and tear strength measurements are not particularly relevant to the clinical circumstances under which implants rupture.

In addition, there is a need to examine whether there is a correlation between MRI findings of rupture or potential rupture with mechanical testing data. A recent article in the European Journal of Radiology reports correlation between MRI findings of silicone breast implant rupture and clinical examination at the time of implant removal. However, it is known in the literature if there is a correlation between MRI findings and implant rupture and mechanical testing of the implant prior to and after implantation.

Mechanical testing prior to implantation could be useful reviewing what type of implants are more susceptible to MRI‑detectable ruptures.

Thank you.

CHAIRMAN CHOTI: Yes? Good morning.

DR. MELMED: Good morning. I'm Edward Melmed. I have no conflict of interest. I am a plastic surgeon who has done breast implants since the day they were introduced. I did my first year of residency in 1963, when Cronin first introduced silicone implants. So I have seen the evolution through the Cronin implant; the Jenny (phonetic) inflatable, which was a balloon through to the silicone pads; the Dacron patches; Meme implants, et cetera.

I wrote extensively about this in the Plastic and Reconstructive Journal in the '90s. But from 1992, I had a complete change‑around. I started seeing the devastation and complications from breast implants. And since 1992, I have explanted over 800 women with breast implants. I wrote about this in Plastic and Reconstructive Surgery in 1998.

My statistics that I wrote in 1998 showed a rupture rate at 10 years of approximately 50 percent, a rupture rate at 15 years of 70 percent, and a rupture rate at 20 years of 94 percent. My current figures show no deviation from this. It's a time‑dose‑related phenomenon. Research that shows two, three, or four years' duration, my statistics show the same. It shows a four percent rupture rate.

The problems become manifest the longer the implants are in. The implants will rupture and just disintegrate. And sometimes no wall of the implant can be found.

I have brought some short clips that I'd like to just show in the background of what implants really look like when you get into the 10‑15‑year rate of removal. The silicone will simply well out with no visible evidence of any wall.

Now, if we take the statistics that are currently available, approximately 330,000 women received breast implants in ‑‑ at least 2004. If we extrapolate that figure ‑‑ sorry. Let me backtrack and say that if we accept that no medical device is safe ‑‑ and I think we must say that ‑‑ then just assuming there's one percent failure rate, at 10 years, you're going to have 33,000 women with problems, which if it becomes 3 percent is 100,000 women.

Now, no batch can be identified of what implants disintegrate. So we're left with this uncertainty of the future of these women. So a girl of 16 who you are going to allow this device in is very different from the 70‑year‑old who has a hip prosthesis that might fail, a woman who is going to be left with an inevitability of having four or five operations in their lifetime.

Lastly, how do you recall implants? If I buy a new Ford and it has a brake problem, the National Highway Traffic Safety will report it if there was more than one percent failure rate. Here we've got 17 percent failure rate. How do we recall them?

Thank you very much.

CHAIRMAN CHOTI: Sir, we have a question here. Yes?

MEMBER LI: This is Steve Li, Dr. Melmed. Just one quick question. Your rupture rates, was that your own personal experience of your own patients?

DR. MELMED: That's our own personal experience in practice.

MEMBER LI: And roughly how many patients was that?

DR. MELMED: That was over 500 patients.

MEMBER LI: And just over what calendar period?

DR. MELMED: From 1992 until 2004.

MEMBER LI: Thank you.

CHAIRMAN CHOTI: Yes? Good morning.

DR. ZONES: Good morning. I'm Dr. Jane Zones, a medical sociologist here representing Breast Cancer Action as a member of its board of directors.

Breast Cancer Action is a national grassroots membership‑based education and advocacy organization that works to make the changes necessary to end the breast cancer epidemic. BCA has a corporate donations policy that forbids us from accepting donations from any entity that might present a conflict of interest. This includes not only all health industries but organizations whose products or manufacturing processes may contribute to cancer incidents generally.

We have no financial interest in the outcomes of these hearings.

Breast Cancer Action's major concern is the continued lack of data to assure long‑term safety and the need for specific guidance for women seeking reconstruction after mastectomy that would allow making an informed decision about the silicone breast implants. In particular, we are disturbed by the data supplied by the applicants on short‑term complications and resurgeries that are particularly prevalent in women undergoing reconstruction after mastectomy.

We are grateful for the care which the FDA staff analyzed the data submitted by the applicants and agree with FDA's analysis that the assumptions employed in industry's projections improperly minimize the risk of rupture in the future.

We have many breast cancer‑related concerns with silicone breast implants. Today, however, I would like to address a topic not specific to breast cancer, which is post‑marketing surveillance.

At the October 2003 meeting of this committee, Inamed struck a deal that promised ongoing follow‑up of women in their studies in return for a conditional approval by the panel. This appeared to have been negotiated with at least some on the panel behind closed doors during the night before the vote. By early in the morning on the last day of that meeting, dozens of copies of the proposed agreement had been duplicated and were handed out to meeting participants.

Since the FDA Modernization Act authorized FDA to conduct post‑marketing surveillance of drugs in 1997, hundreds of new drug reviews have required Phase IV post‑marketing clinical studies as conditions of their approval.

In their most recent report to Congress, the FDA indicates that over two‑thirds of new drug approvals with open post‑marketing commitments had not yet initiated required Phase IV studies.

The situation for medical devices is even less developed. In June 2002, FDA announced plans to require manufacturers of some devices to conduct post‑marketing surveillance for up to three years. Breast implants are covered by this rule because the category includes medical devices implanted for more than a year.

However, there is no reason to expect device manufacturers to be any more compliant than pharmaceutical companies in their pursuit of post‑market approval data. In fact, an article in the Wall Street Journal less than two weeks ago quoted an internal report by FDA scientists, saying that the CDRH had only limited procedures for monitoring manufacturers' progress and results.

Of 45 devices conditionally approved between '98 and 2000, nearly two‑thirds included no information about post‑marketing studies in manufacturers' annual reports to the FDA. Final results on over half of studies that were known to be due had not been submitted.

FDA has little recourse where manufacturers either fail to meet post‑marketing commitments or find evidence of greater risk except to pull the product from the market. This has never happened with devices nor, as far as I know, with drugs.

The dramatic removals we have witnessed in recent years have usually involved whistle‑blowers, leaked documents, journalistic exposes, or unexpected findings from post‑market studies designed to broaden indications for use of the product.

Inamed and Mentor have proposed up to ten years of total follow‑up of the women in their studies, but the medical device regulation has an upper limit of three years, which, if effected, would preclude prospective analysis of the effects of aging of the implants, which are thought to rupture at increasing rates.

We urge the panel to act on the data that is now before you and not on that which may be promised in the years ahead. The manufacturers know that it is unlikely that you would ever be called to review post‑market surveillance data in the future and that the consequences for less than quality follow‑up or for findings of greater risk are minimal.

Women who are at risk for breast cancer or who currently are living with the disease are depending upon you to hold these devices to a high standard.

CHAIRMAN CHOTI: Thank you.

Next speaker, please.

MS. PAM DOWD: Hello. My name is Pam Dowd, and I have been asked to speak on behalf of Cristy Warschaw, founder of Women in Health, one of the largest support groups in southern California for silicone breast implant women. Neither she nor I have any affiliation with Inamed or Mentor. Neither of us have received monies from either company for this testimony.

"I, Cristy Warschaw, have had both Inamed and Mentor post‑1990 silicone breast implants. I am unable to attend this hearing because of my continued health problems associated with these implants.

"My history is very simple. No health problems until November 1989, when at age 28 I underwent a mastectomy with reconstruction with silicone breast implants.

"I had a family history of breast cancer and calcified fibrocystic disease. I became ill as soon as the implants were placed. I had to stop working as a medical administrator and stop my Master's degree program at UCLA.

"I have been on disability for most of the last 16 years. I have had seven surgeries, all associated with the implants. As of today, at the age of 43, I have undergone total mastectomy with no further reconstruction because I am not a candidate for TRAM flap or any other reconstructive surgery.

"It has been discovered that I am one of a few people allergic to silicone. If I even ingest milk, I can have an anaphylactic reaction as silicone is used as a defoaming agent in processing. I cannot place any silicous, silicones, dimethicones, or any cones on my body because I will break out in a rash.

"IV needles are coated with silicone, and I have not been able to keep one in me for more than one day because of the silicone reacting and inflaming the IV site.

"Having been a support group leader for 12 years and having had both manufacturers' implants, I have done a lot of investigation on both companies. My number one concern is the FDA 483 inspections. Inamed is manufacturing its SBIs in Costa Rica. By what means is the FDA inspecting this manufacturing plant?

"Mentor's manufacturing facilities in Texas have failed viscosity, dipping, and humidity control over and over again. Also, medical device reporting has also proven to be a problem as well.

"If the FDA is taking Inamed's chemistry and mechanical testing from only Inamed's say, then this is a complete failure on behalf of the FDA. It is also jeopardizing every woman receiving an SBI.

"Neither company has ever been able to assure shell thickness during the dipping process due to inability to control humidity. So they cannot predict clinical outcomes, as requested by the FDA, because each lot will produce a different result.

"As a health care professional who has kept clinical data for FDA experimentation and clinical trials, I have great anxiety in allowing silicone breast implants to be placed back on the market.

"Also, having been a support group leader and seeing women affected by SBIs, I know how people fall out of the studies. Women will not see a reason to follow up in‑house with a plastic surgeon at the recommended intervals.

"There is no way a physician can detect a silent rupture. MRIs cost thousands of dollars. The study is already set up to fail. Women move. Women with SBIs are being treated for cancer. Therefore, there is a higher mortality rate for these women.

"No guards are set in place to retrieve post‑mortem implants for study. There is a strong possibility these women can lose health insurance and will not return for follow‑up appointments.

"Women will have a problem and not return to the same surgeon. They may very well go to a surgeon who is not part of the study. What happens to those implants?

"Women do not relate their fatigue to implants and are seen by their personal M.D.s for this and may not relate these to silicone breast implants.

"I have had four different surgeons and to this day and am in possession of four of my five implants. The silent contained rupture was not noticed on MRI two days before I had surgery. Four years after this rupture, I had 15 granulomas relieved from my chest wall by yet another surgeon.

"There has never been an FDA PRP report filed on me or MDR report on my rupture or fungus‑infected implants. I fell through all the loops. And as a support group leader knowing about breast implants, how many of these women will fall through the loops as well? Women with breast cancer are too busy worrying about their lives to think about SBIs. They just want to be whole again.

"I could go on and criticize each part of the draft guidance for industry and FDA staff saline, silicone gel, and alternative breast implants, but that would take up more time than I have. It is my opinion that neither company has met the FDA guidelines to demonstrate a reasonable assurance of the safety and effectiveness of SBIs. Therefore, they should deny approval.

"After ten years of trying" ‑‑

CHAIRMAN CHOTI: If you could sum up, please?

MS. PAM DOWD: Yes. I've just got this one sentence.

"After ten years of trying, yet just not making it, SBIs should be removed from the market altogether."

MS. SMITH‑MILES: Good morning. My name is Rebecca Smith‑Miles, or Becky. I am from northern Michigan. I am a registered nurse. My husband is a radiologist. I have no conflicts of interest.

I had silicone implants put in over 15 years ago. Within two years, I developed capsular contracture and experienced intense pain. My plan to be more beautiful was ironic in that I was uglier by the day. I had larger breasts, but they were hard, painful, and ugly. I was ashamed for even my husband to see them.

Within seven years of getting the implants, I was diagnosed with an atypical neurological disease. Eight years after being implanted, I had my implants and scar capsules removed. They had ruptured. And the plastic surgeon attempted to retrieve all of the leaked silicone, but he was unsuccessful.

If I had been included in the three‑year and four‑year studies at that time, only capsular contracture and pain would have been picked up, not the rupture and not the systemic problems.

I have gone from being a very athletic and active person to being physically inactive and at times bedridden. I worked daily prior to getting implants. Now I'm on disability. And sometimes I'm even unable to perform my daily household tasks, simple tasks.

I have severe overwhelming fatigue, joint and muscle aches, pain, dry, scratchy eyes, skin rashes, numbness in my calves and toes, hair loss, night sweats, and daily headaches. I am easily confused and have a constant fog in my head.

My skin develops rashes and reacts to previously normal substances. I have blister‑like eruptions in my fingers that are intensely painful. And along with the pain comes burning and itching and total intolerance to any pressure. I can't use that finger. I scratched it and scratched it until the top came off. And then I felt with my tongue a tiny sliver of crystal. When I got that crystal out, it healed immediately.

I fear that I have silicone crystals running throughout my body, and I wonder what kind of damage it has done to my internal organs. I had silicone leakage in my chest, axillary lymph nodes down my arms.

My last surgery a year ago removed silicone after an ultrasound located it in my chest and breasts. I had a lemon‑sized portion of my right breast tissue removed as a result of the leaking silicone from the rupture over ten years ago. The surgery has made that right breast noticeably smaller, but it's worth it.

My life since getting implants has changed completely. My social and family lives have suffered. I can no longer be a normal wife, mother, or grandmother. Even so, I'm lucky because my husband is a physician, and we are not financially devastated by my disability.

I beg you, as you make this very important decision, think not only of my experience but also of the lives of other women, your friends, your relatives, who may end up like me. Silicone breasts are not worth the known risks, let alone the unknown long‑term risks.

Thank you. Any questions?

CHAIRMAN CHOTI: Thank you very much. Good morning.

MS. DALY: Good morning, ladies and gentlemen. My name is Anna Daly, and I'm from Nashville, Tennessee. I was asked to come and speak to you today by my plastic surgeon, Dr. Melinda Haws, of the Plastic Surgery Center of Nashville, and the Inamed Corporation, who provided my transportation and lodging.

On December 30th of 2003, I had my very first mammogram. On January 26th of 2004, I was diagnosed with ductal carcinoma, breast cancer, on my left side. Though the cancer was still fairly small and had not yet spread, it was labeled as high‑grade and aggressive. And I was not yet 40 years old, with a 2‑year‑old and a 4‑year‑old at home.

After speaking with my family and the doctors involved, we decided the best option would be to undergo a bilateral mastectomy with immediate reconstruction using tissue expanders, which I did on February 13th. The choice was made because of the nature of the cancer, the probability of it recurring on the opposite side, and the symmetry that would be provided by doing both sides at once.

During the next five months, we discussed and researched my implant options: saline versus silicone, smooth, textured, and size. The tissue expanders that I received were saline‑filled. And my experience with them was not a pleasant one. I did not like the fact that I could hear the liquid sloshing in my chest, nor feel the saline moving from side to side as I walked, caused several cases of severe motion sickness that I did not want to repeat.

Appearance was also considered. I didn't like the way the saline‑filled implants have a tendency to ripple. And the profile of the implants did not appeal to me. So I made my decision.

After signing a waiver regarding the possible side effects and enrolling in a research study to be conducted over the next five years, I had my tissue expanders removed. And I chose to have silicone‑filled implants on July 1st of last year.

I like the projection of my breasts that the silicone‑filled implants provide because it is very natural. The feel is also very natural to the touch. And they are as close to the feel of my own breasts that I could have imagined.

After going through the invasive nature, trauma, and emotional upheaval of a mastectomy, appearing and feeling normal become very important to you. Important also is the fact that I have a choice in the type of implants that is to be placed in my body.

So many choices are already made for you when you are faced with a cancer diagnosis. Knowing that I could help choose the way I would look coming out of this was very empowering and very uplifting.

My request of you is to clear the way for silicone implants to be a choice for all women, reconstruction or augmentation, research study or not. We all deserve to feel beautiful and, if not beautiful, at least normal.

CHAIRMAN CHOTI: Good morning.

MS. ANTOLICK: Good morning, ladies and gentlemen. My name is Karen Antolick. And I live in Columbus, Mississippi. I have no conflicts of interest.

My desire for implants began at the age of 15. And then at the age of 22, I took my savings along with a small loan and had silicone breast implants placed.

I was told by my plastic surgeon that sometimes implants could hard and have to be replaced but that if I massaged my breasts as instructed, that this was most likely not going to happen. I was told that breast implants were a lifetime investment and safe. I also did not receive any literature outlining the potential risk.

I thought that my life could only improve with implants. And after my surgery, I felt implants were the best thing that had ever happened to me.

Within the first year, however, I began having serious medical problems. Over the years, I was in and out of doctors' offices with various symptoms: chronic fatigue; memory loss; migraines; chronic pain; hearing loss; burning in my chest; and numbness in my lips, hands, and feet. I did not know, nor did the doctors, that most of these symptoms are autoimmune symptoms and common with breast implant patients.

The pain and burning in my chest along with nipple discharge became so severe that I went to a plastic surgeon to have the implants removed. Once removed, my doctor told me that both implants were ruptured, capsulated, and had been leaking for many years.

During the surgery, she removed lymph nodes because they had become contaminated with silicone. This was very surprising to me because each year my mammogram showed that my implants were intact.

I am not unusual. I now know that FDA study found that most augmentation patients had at least one broken silicone implant within ten years. And silicone migrates outside of the breast capsule for 21 percent of women with implants.

I was young and naive when I received implants. I didn't have the foresight to see that my health is much more important than my breast size. Instead of providing me with self‑esteem, like I thought, they provided me with a life of pain and dependency.

Now, 23 years later, I can no longer work as I used to. I had to move closer to my parents so that they could help care for my children. Probably the most difficult change I have had to come to terms with is not being able to care for and enjoy my children the way that a mother should.

Please make sure that young girls who are considering implants will not have to sacrifice their health for a certain body type like I did. Thank you for your time and consideration.

DR. TEBBETTS: Good morning. Dr. Choti, members of the panel, I am Dr. John Tebbetts. I am a board‑certified plastic surgeon. And my testimony this morning is based on 26 years of clinical experience performing breast augmentation; 17 years of experience designing breast implants; and my peer‑reviewed publications, which I have provided members of the panel.

I have a conflict of interest but not with the devices here today. I have designed devices for Inamed Corporation, received compensation as a consultant. None of my devices are under consideration. And I am here today to speak to you about an issue that really applies more to all devices but has concerned me for some time.

For the past 15 years, through 3 PMAs for totally different devices, surgeons, plastic surgery organizations, and manufacturers have not improved the 15 to 20 percent 3‑year reoperation rates for primary breast augmentation. I believe that one of the main reasons for that is that our educational methods are not sound.

Although we have provided information and previous panels have made recommendations about specific information to be provided, we are not teaching patients and surgeons how to make decisions. We are not testing to ensure that the information has been delivered. And we are not providing incentives to assure implementation of best practices that we know by peer‑reviewed results have been proven.

The bias characteristics affect outcomes in only a percentage of cases while patient and surgeon decisions impact outcomes in every case, regardless of the device and often far more than the device itself.

As we listen to saga after saga of compromised outcomes, we should be asking ourselves, was it the device or was it the decision‑making process of the patient and the surgeon. Could the saga have been avoided or at least terminated early by simply applying endpoints, removing and not replacing the implants?

The best indicators of quality of surgery are the patient experience and reoperation rates. Today, over 80 percent of augmentation patients can be out to dinner the evening of surgery without bandages, drains, pain pumps, or narcotic pain medications.

And 96 percent of those patients can return to full normal activity the next day with a 3 percent 7‑year reoperation rate. Most patients have no idea that this level of outcome is routinely possible and even being delivered by surgeons less than ten years in practices.

The processes and practices that generate these peer‑reviewed results can directly impact outcomes and reoperation rates but only if they are transferred through optimal education.

Improving patient outcomes requires accountability from those who make decisions and from those who provide education and who want to provide certification.

I hope that, as you consider these devices and other devices, you will make strong recommendations in that regard. There are good solutions. Time does not allow me to go into them today.

Thank you for your time and the opportunity to address the panel.

CHAIRMAN CHOTI: Thank you.

Good morning.

DR. FRAGEN: Good morning. I approached Inamed and Mentor and volunteered to come here today to speak to the panel. I am a member of their institutional review boards. And Inamed did provide for my transportation. I am kind of a gray‑haired doc. And I thought it would be interesting to give you my perspective.

My name is Ronald Fragen. I am a physician and surgeon who has been performing breast implant surgery for 30 years. I practice in Palm Springs, California. I have traveled across the country because I believe women are able to evaluate the risks of breast implant surgery and make their own decisions without restriction. To my knowledge, no other country restricts the use of silicone gel implants and 60 countries have approved their use.

I was licensed to practice medicine in 1964 and began practicing medicine in California in 1971. I have performed breast augmentation surgery for 30 years.

Just so you know me, I was an Assistant Professor at the University of California Medical School at Irvine for 20 years. I am the past President of American Society of Cosmetic Breast Surgery, past President of American Society of Liposuction Surgery, past President of California Academy of Cosmetic Surgery, and a member of the board of directors of both the American Academy of Cosmetic Surgery and the American Board of Cosmetic Surgery. I have practiced exclusively cosmetic surgery for 20 years.

I have seen nearly every breast implant ever used. The current silicone breast implants have been used in my practice since the mid 1980s, when they were first introduced. I have patients who have had these implants in for 20 years.

With the old implants, 20 to 25 percent of our breast surgeries every year were revised problems, usually capsule contracture or rupture. In the last 20 years, I cannot find 15 patients who have needed revision surgery using the new gel implants.

I have done thousands of breast implants. The new implants have a thicker shell and a coherent gel that doesn't run. The old implants had a thin shell, more fragile, a gel that flowed like sticky molasses. Since using the new implants, I have seen only one shell split. And that gel did not leak. It behaved like cut Jell‑O. There was no leakage.

Do not mix the results from old implants and the new thick‑shelled implants with coherent gel. These new implants are safe. By comparison, aspirin is not safe. Skateboards, skiing, motorcycles, alcohol, tobacco, and exhaust from automobiles I think are far more hazardous.

Women have many breast deformities: congenital; small; malformed breasts; breasts that change after cancer surgery; and the largest group, those whose breasts have become deflated skin sacs after pregnancy.

Most of these patients I see fall in the latter category. They cannot wear clothes they desire and often lose self‑esteem. They desire to regain their shape. We allow women who have congenitally deformed breasts and women who are cancer survivors to regain their shape using silicone gel implants. These women and their surgeons pick the best implant to fit their anatomy without restriction from the FDA.

Implants are safe for these people. Why do we trivialize post‑pregnancy breast deformity and not allow these women and their surgeons free access to the best implant for their particular anatomy? We should.

These implants are safe. Saline implants are stiffer. They ripple. And they more often give a balloon‑like shape. However, they are easier to implant. It's an easier operation for the surgeon than a silicone gel implant is. A silicone gel implant is a better choice for the patient in many instances, however.

CHAIRMAN CHOTI: If you could wind up, please?

DR. FRAGEN: Yes. These implants are a new and better machine and should not be compared to the old implants. This is really a woman's issue. The surgeons have no secondary gain to use silicone implants.

I just want to tell you that one of my reasons for going into medicine was an aunt who started practicing medicine right after World War I before the Nineteenth Amendment to the Constitution was enacted. That's the women's right to vote. I'm sure she would not have ‑‑

CHAIRMAN CHOTI: Sorry.

Next speaker? Good morning.

DR. KASPER: Good morning. My name is Anne Kasper. I have worked in women's health for 30 years. I have been a breast cancer counselor for four years in Bethesda, Maryland. I am also the Breast Cancer Counselor for Mobile Medical Care, which serves the uninsured, low‑income, and homeless of Montgomery County, Maryland. I am the Senior Editor of Breast Cancer: Society Shapes and Epidemic, a book published in 2000.

The women I counsel who have faced breast cancer have one primary concern. They want to survive this disease and live out their lives for as long and as healthy as possible. Women want to be able to trust that the treatments and recommendations given them by health professionals, science, researchers, and drug and device manufacturers will halt the progress of the disease and promote their health and well‑being. Few women want to take any unnecessary risks with their health once they have faced a diagnosis of breast cancer and endured its treatment.

For many women who have undergone the loss of a breast looking and feeling normal and comfortable without further health risks involves no more than a good mastectomy bra and well‑fitted prosthesis.

Many women who are offered breast reconstruction refuse it because they don't want to undergo further surgery, anesthesia, risk of infection, and recovery. They are also concerned that a breast implant will obscure finding a breast cancer recurrence or that the implant will rupture and further surgery will be needed.

There are also many more options than there used to be for breast cancer patients who want to keep their breasts. More than three out of four of the women who are newly diagnosed with breast cancer are eligible for lumpectomy and, therefore, won't need reconstruction.

The number of women who need a mastectomy, instead of a lumpectomy, is much smaller than it used to be. In addition, women who undergo mastectomies have other alternatives to silicone breast implants. Saline breast implants have a lower complication rate and do not cause, as far as we know, the serious problems if they leak as to silicone implants.

Many women tell me that they don't want silicone breast implants because they have never been proven safe specifically for women with breast cancer. Having endured cancer in their bodies, women tell me that the last thing they want to do is willingly introduce a foreign substance that has not been proven safe over the long term, will rupture in time, will leak silicone into the body, will interfere with mammography, and may cause additional health problems as well as repeated surgeries.

Implant makers tell us that women need silicone gel implants for their emotional well‑being. Today you're hearing from patients who say they want implants to help them feel better about themselves and that it improves their quality of life. However, we know that there are no studies to support that claim.

A study by Dr. Julia Roland and Dr. Patricia Ganz and colleagues compared the quality of life of women who underwent lumpectomy, women who underwent mastectomy, and women who had mastectomy with reconstruction. They found no difference, no difference, in quality of life between the three groups of women.

There were some differences in certain aspects of their lives, however, but the reconstruction patients were not necessarily the happiest ones. As I consider the needs of the cancer patients I work with, the lack of long‑term safety data and the lack of evidence that breast implants improve women's quality of life, I don't see a reason to approve silicone gel breast implants.

I urge the FDA to once again deny approval to silicone breast implants. If the companies finally develop a safer implant in the future, the FDA can then reconsider.

Thank you.

CHAIRMAN CHOTI: Thank you.

Good morning.

MS. BEAGLE: Good morning. My name is Kitty Beagle. And I am here today speaking on behalf of Anna Carpenter, who was, unfortunately, unable to attend the meetings.

"My name is Anna Carpenter. And I am a member of the Younger Women's Task Force. The task force is a project of the National Council of Women's Organization, which represents over 200 women's groups across the nation. As a young woman in the age of cosmetic surgery, reality shows, like 'The Swan,' 'Extreme Makeover,' and 'I Want a Famous Face,' I'm here to talk about what kind of risk these devices pose to women in my generation.

"Our parent organization is the sponsor" ‑‑

CHAIRMAN CHOTI: Excuse me. One moment. I wonder if the group who is walking back there, if you could just hold off on that so we can hear the discussion. Okay? The point is for the speaker to speak at the podium if that would be all right. Thank you.

I'm sorry. Continue.

MS. BEAGLE: Thank you.

"Our parent organization is the sponsor of the Extreme Measures Tour, a body image campaign which is traveling the campuses across the nation featuring young women telling their peers about their personal experiences with failed breast implants. The response has been astounding.

"On one Texas college campus, the school's volleyball coach asked that the speakers would visit with the local girls' high school team because all of the players were insistent that they would receive breast implants on their 16th birthday.

"At a New Jersey campus, audience members told story after story of young women receiving complication‑laden breast implants before rushing sororities.

"The extreme measures campaign Web site has received e‑mails from women on campuses across the country asking that the tour visit their school. Why is this happening? Why are women on college campuses so eager to hear about their peers' experiences with breast implants?

"Look at the numbers. The American Society of Plastic Surgeons recently reported that this past year, 3,962 augmentation procedures were performed on women 18 years and younger, a shocking increase from the roughly 400 procedures done on the same age group in 1994. Three thousand, nine hundred, sixty‑two means approximately ten teenagers receive breast implants every day.

"According to manufacturers' own data, 21 percent of these teens will require reoperation within 3 years. That means that every day, 2 of those teens going under the knife will be back on the operating table within 36 months. That is not including the staggering numbers of young women who will experience what is termed 'local complications.'

"Surgery is surgery. And it carries inherent risks, no matter how minor the procedure is billed to be. Manufacturers state that breast implants will need to be replaced every ten years.

"A young woman who receives breast implants on her 18th birthday and lives to be 88 will need at least 7 sets of implants in her lifetime, each time paying out of pocket for the removal of the old sets and implantation of the new sets, because health insurance rarely covers the cost of problems related to breast implants.

"Even more troubling, many insurance companies will not enroll a woman with implants. Few teens can grasp the significance of what having health insurance means, let alone how not having it could create extreme financial hardships in the future.

"As a young woman, it is also hard to understand the importance of early detection and mammography. Mammography misses 55 percent of the cancers in women who have implants. Will young women take this into account when considering implants?

"Although some cosmetic surgeon groups may not endorse silicone implants for use in teens, I will remind you that the FDA does not have a mechanism to police the sale of implants once restrictions are lifted. I will remind you that Dr." ‑‑

CHAIRMAN CHOTI: If you could wind up, please?

MS. BEAGLE: Thank you.

CHAIRMAN CHOTI: Sorry. Thank you. I apologize, but we really need to try to stay on time. Thank you.

Next? Good morning.

MS. HEIDE: Thank you. Good morning. And thank you for the opportunity to speak here today.

My name is Terry Heide. I am 51 years old, married with no children. And I work as the congressional liaison for the Department of the Army's contracts for the reconstruction of Iraq.

I was diagnosed with breast cancer in January '03. I had bilateral mastectomies in July '03 and reconstruction with tissue expanders. I received my permanent silicone implants in October '03 and have had no health problems since.

I also have no financial interest in Inamed, Mentor, or any other medical company. And neither Inamed nor Mentor nor anyone else is paying any expenses associated with my appearance here today. Those are the facts about me, but it is not who I am.

Who I am is an intelligent, educated, and compassionate woman who knows her own mind. Who I am is a woman who has always made decisions, tough decisions, using the best information available. Who I am is no different than any other woman who has faced challenges and triumphs, loss and recovery.

Like many other women, unfortunately, I had breast cancer. But, unlike thousands of other women who are diagnosed every year, I did not require chemo or radiation. I had my first surgical biopsy when I was 19 years old. So I have been closely monitored my whole adult life.

I was lucky my cancer was caught early and was easily treated. I was also lucky to have my choice of implants. And never once did I consider any other option other than silicone.

I am well‑read regarding the science on silicone implants. And, again, being in the business that I am, I am also well‑aware of the politics of breast implants. This here today is about politics, not science.

Silicone is a common material in a wide variety of implantable medical devices. And there are even acceptable medical uses of liquid silicone. And none of these other products or uses have been restricted or banned. It is only breast implants.

There are also many implantable medical devices that fail at a rate equal to or greater than the rate at which silicone implants might fail. And none of those other products have been restricted or banned. It is only breast implants.

The reason I believe is because silicone breast implants are a woman's health issue. And there is an assumption at work here that women are incapable of making sound and rational decisions about their health or their bodies, that somehow we need to be protected from ourselves simply because we are women.

Silicone is the closest to real breasts. It looks the closest to real breasts and feels the closest to real breasts. But it is not right for everyone. The decision to have a mastectomy or reconstruction or augmentation or saline or silicone implants is an individual decision and one that can only be made in consultation with a woman's doctor. But this here is not about science.

Yes, implants fail and planes crash and people get cancer. There is no guarantee that life will be as we wish it to be. We all make decisions every day about how we live our lives that involves risks. There are hundreds of products out there made to make people feel more whole, such as hip replacements and titanium rods that go into people's back. And all of these things ‑‑

CHAIRMAN CHOTI: If you could sum up, please, for us? Thank you.

MS. HEIDE: Thank you.

CHAIRMAN CHOTI: Just sum up for us, if you would, please?

MS. HEIDE: Oh, yes. My concern is that I wish there was no breast cancer. I wish we weren't here today. I wish that everybody had the body and the breasts and the health that they wish for. But, unfortunately, that isn't how life works.

And I am extremely concerned that the FDA would make women come here and talk about this most private of things.

CHAIRMAN CHOTI: Thank you. I'm sorry.

Next speaker? Good morning.

MR. MILLER: My name is Steve Miller. I have no conflict of interest. My wife is here today. And she will be sharing her story about how silicone implants she received for correction of a congenital defect have harmed her.

I am reading this testimony on behalf of another man whose wife has also suffered greatly due to silicone implants. I am here to read the testimony of T. Wade Clegg of Panama City, Florida who could not be here with us today. He has no conflict of interest.

"My family life has been severely affected by my wife's disastrous experience with silicone gel breast implants. That is why I wish to share my thoughts with the Advisory Panel.

"I believe that silicone gel is one of the most insidious and invasive products ever allowed in the public marketplace. Silicone can migrate to distant places within the body, such as the liver, thyroid, under the arms, into the arms, and across the chest. Such was my wife's experience.

"For years, her neck would swell and diminish, blocking her breathing. Her thyroid was removed, and the pathology report said it was Sjogren's disease. She is now on permanent medication and must wear a 24‑hour opium patch.

"Sjogren's disease, by the way, can take years to diagnose. Only long‑term studies will be able to show whether implants cause this disease.

"My wife was not informed about the dangers of silicone breast implants. She is serving a life sentence of pain. Normal for my wife has become a loss of physicality, loss of sleep, and diminished health, which has led to massive medical bills, bankruptcy, the loss of our farm, and a downward spiral resulted from silicone gel breast implants.

"Most women do not know that silicone gel can calcify and mix into breast tissue. The pain can be extreme, as in my wife's case. Once this takes place, the surgeon has to literally scrape the silicone off the chest cavity until there is nothing left. This was my wife's experience.

"My wife no longer has breasts. For women of childbearing age, this is particularly devastating and can mean the inability to breast‑feed.

"The FDA had questions about the safety of implants last year and didn't approve the application for implants back then. The real question is, have the manufacturers really answered all of these questions in the space of one year? Since only four years worth of data is being presented, I doubt it.

"Please ask yourself, if the same question exists, then why are we here? I plead with this FDA Advisory Committee to continue to restrict silicone gel implants while research continues. Do not improve implants which have not been proven safe for long‑term use. This is not about aesthetics. It's about women's health.

"Thank you."

MS. STANSELL: I was supposed to have five minutes.

CHAIRMAN CHOTI: Please go ahead. Yes.

MS. STANSELL: Okay. Thank you.

My name is Anne Stansell, and I have no conflicts of interest. I represent a support group of about 45 women, all with experiences similar to mine. One, Ann Palmer, a cancer survivor, was in the Mentor study. When her silicone implants ruptured at about two years, she was dropped from the study. And her record at Mentor and, thus, presented to you tomorrow shows no adverse effects. Ann Palmer died of breast implant complications in 2001.

I was diagnosed with breast cancer when I was 39. I underwent a mastectomy, radiation therapy, and breast reconstruction with silicone implants. Four doctors recommended that I get silicone implants. At the time there was no research on silicone breast implants in cancer survivors. But none of the doctors told me that. Not one of them told me about the risks, the fact that they can rupture and leak silicone and other chemicals into my body.

Because of these chemicals in my body, I now get severe headaches when I am exposed to any common household products with phenolic disinfectant, such as Lysol.

After six years, I started to get sick with joint pain, muscle pain, skin problems, dry mouth, and dry eyes. My eyes are so dry that it has caused a retina to tear. These are all autoimmune symptoms.

I was also diagnosed with an autoimmune symptoms called Grave's disease. After fighting cancer, the new illnesses caused by my implants, I then had to fight with my insurance company to have the implants removed. You see, the law states that they must provide implants for mastectomy patients. There is no law that says insurance companies must replace them in case of rupture or remove them in case of adverse effects.

When my implants were removed, half of one of them was gone. This is not surprising given that Inamed's own data shows that 20 percent of reconstruction patients experience ruptured implants within just three years. Studies have shown that silicone can leak into the scar capsule and the lymph nodes, even when the implants haven't yet ruptured.

After I had the implants removed, I started to slowly get better. This is also typical. I have read a study by National Cancer Institute researcher Dr. Noreen Aziz which shows that most women with implants who have rheumatological symptoms get better when their implants are removed and not replaced. If their implants were replaced, most got worse.

I am not fully recovered, unfortunately. In addition to continued fatigue, the many surgeries to put in and remove my implants had left me with such chest tenderness that I cannot have anything more than a soft t‑shirt on my chest. Now prosthetics even are out of the question.

This controversy has been going on for 15 years. The whole new generation is now being seduced into believing these products are safe when they are not.

No significant improvements have been made in silicone breast implants in the last 15 years. This is the same product with new advertising and new hype. Just because these manufacturers have created a market for their products with advertising and TV makeover shows does not mean the product is safe.

If you want to help breast cancer patients, please insist on long‑term safety data before approving this product. You owe it to us older women who have suffered for years and years and to the young women who will suffer for many years if you approve this product.

CHAIRMAN CHOTI: Thank you.

Yes? Good morning.

DR. TAYLOR: My name is Dr. Joy Taylor. I was a hospice physician. I have no financial ties to the manufacturers or their competitors.

I had breast implants for 18 years before I became ill. A CT scan showed bilateral ruptured implants, and I was diagnosed with pleurisy and pulmonary fibrosis. I then began collecting autoimmune disorders.

I was diagnosed with Hashimoto's thyroiditis, Sjogren's syndrome, autoimmune diseases that attack the thyroid, the salivary, and the tear glands. I also developed polymyositis, a coagulopathy, Alzheimer's‑like symptoms, severe fatigue, MS symptoms, constant tinnitus, and Crohn's disease.

My colon was perforated in several places and had to be removed. I was in ICU for over six weeks and on life support and had every complication possible.

The ICU doctor told my family that in 30 years, he had never seen anyone in my condition survive. He told my family to make arrangements for my funeral. I lived through that crisis, but there were more to come because my body was producing antibodies that attacked me.

In addition to all of this, I suffer the debilitating disease porphyria. There are only two ways to get porphyria: exposure to heavy metals, like platinum; or heredity. I have no family history of porphyria. Platinum exposure causes malfunction of the immune system.

Since my implants ruptured, I have had ten surgeries. My family has planned my funeral twice. And I am unable to practice medicine. I regret my decision to get implants. And I am alive today because of the skillful, caring doctors and many prayers. The ICU doctor says I am a miracle, and he is right.

Please don't approve silicone implants until they are adequately tested long‑term and proven safe. Women, after all, have the right to have accurate information on which they may make an intelligent decision. Women's health and lives depend on it.

CHAIRMAN CHOTI: Excuse me. Were you representing an organization for that session?

DR. TAYLOR: Yes, Platinum Awareness.

CHAIRMAN CHOTI: Thank you very much.

Yes? Next speaker, please. Good morning.

MS. MARSHALL: Good morning. Good afternoon. Hello. My name is Cindy Marshall. Here's my story, which is, sadly, just one of literally hundreds of thousands of similar stories.

Silicone gel implants have destroyed my precious, priceless health, drastically changing forever the quality of my life. Women like me are proof of the truth.

I still remember the words that board‑certified plastic surgeon spoke to me, "These implants are safe to last a lifetime." What a wonderful 21st birthday gift, "You'll forever love how you'll look and feel." If only his words were true.

I first experienced flu‑like symptoms, hair loss, bone pain, fatigue, which resulted in countless doctor appointments. I had three mammograms, beginning in 1997, then in 2000, last in 2003.

The last mammogram indicated that my silicone gel breast implants were leaking and ruptured. I had to get explanted quickly and was in May 2004. By this time, it was too late. The damage was already done. My silicone gel breast implants had leaked and ruptured, leaving me with currently irreversible damage, silicone poisoning, and silicone‑associated disease.

Here are just some of the numerous symptoms, conditions, and diseases: swollen lymph nodes; hair loss; chronic bone muscle; skin tissue and organ pain; connective tissue disease; arthritis; scalp, face, body rashes; vision problems; blood in stools; blood leakage from breasts; chronic weakness, fatigue; Raynaud's syndrome; irreversible brain damage, demyelinating disease; MS‑like.

I used to have a business in home health care. Now I am the patient. I experience scary, unpredictable episodes and attacks during these times in which I have slurred speech, severe termor, difficulty walking or fall down, and even episodes of paralysis.

I must depend on others for my daily needs because of my difficulty performing. I have difficulty performing even the simplest of tasks: using the bathroom, showering, dressing, and feeding myself. One of my doctors now thinks I have lupus.

If I had been informed of the truth that silicone gel implants were never proven safe, that they leak, rupture, and bleed toxic substances into the immune system, contain close to 40 known toxic chemicals, mind you, not meant for human consumption, never ever would I have consented or allowed them to be put into my body.

I'm only 37, a single mom of 3 beautiful girls. I just want to be here for Brooke, Erica, and Danielle. My children who need their mommy fear for their mommy, who fears for every young girl and woman everywhere.

FDA, please support public health safety and not the industry poisoning the public. Thank you.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. MILLER: My name is Dr. Claudia Miller. I have no financial interests in this hearing, and I'm here at my own expense. I'm actually a professor at UT Health Science Center in San Antonio. I'm an allergist/immunologist. And my research is focused on people who report chronic disabling symptoms following some environmental exposure, the symptoms you have heard about today.

I have served as a consultant to the Department of Veterans Affairs on Gulf War veterans, the EPA on sick buildings, the National Institute of Dental and Craniofacial Research on temporomandibular joint implants, where, by the way, you see similar kinds of complaints.

What unites ill Gulf War veterans, sick building occupants, and patient with implants who are having problems is the fact that following a well‑defined exposure event, a subset, not every one, a subset of them, go on to lose their prior natural tolerance for a wide variety of substances that are structurally unrelated.

Thereafter, common foods, medications, alcoholic beverages, caffeine, chemical inhalants, like diesel exhaust, and fragrances you have heard about today, exposures that never bothered people before suddenly trigger symptoms in them. And these can be disabling.

This two‑step disease process ‑‑ you can go to the next slide ‑‑ has come to be known as toxicant‑induced loss of tolerance, or TILT. It does not appear to matter whether the exposure that initiated this, which is at the bottom of the right‑hand slide, was endogenous or exogenous. The body's response is remarkably similar.

Next slide. We have reported on 87 individuals with surgical implants, three‑quarters of them with breast implants. Sixty‑nine percent reported rupture. Seventy‑eight percent had one or more implants removed. Of those who had undergone explanation, less than ten percent reported their health status as greatly improved.

Next slide. Using a validated questionnaire, we found that the symptom severity scores of implant recipients rivaled those of the environmental exposed groups we were studying. And there were four of those.

Next. Compared to controls, implant recipients reported much more severe adverse responses to everyday chemical exposures as well as having problems with various foods, medications, alcoholic beverages, and caffeine.

We are a couple of slides behind. Go ahead. Next slide and then the next one. Thank you. And then the next one. Toxicant‑induced loss of tolerance is a new paradigm for environmentally induced disease that differs from classical toxicity and allergy.

Affected individuals may be completely unaware of the intolerances resulting from this because of a phenomenon we call masking. If a person is reacting to many different things and having symptoms as a result of those, then the symptoms may overlap in time. And, consequently, they feel sick all of the time, often reporting chronic fatigue or flu‑like illness that won't go away.

Recent Canadian studies show that genetic polymorphisms may determine who is more vulnerable to developing this illness. And in September ‑‑ next slide ‑‑ I will be chairing a meeting on the toxicant‑induced loss of tolerance sponsored by two NIH institutes where we'll be discussing various aspects, clinical models, animal models, and so on, in order to understand this problem better in providing you with a questionnaire that I showed a moment ago to help physicians and researchers better understand this problem.

And I will be happy to provide you with any references. Thank you.

CHAIRMAN CHOTI: Thank you. And I would like to thank all of the speakers this morning for their time. We are going to take a lunch break now. We are going to resume promptly at 1:15. Thank you.

(Whereupon, at 12:05 p.m., the foregoing matter was recessed for lunch, to reconvene at 1:15 p.m. the same day.)